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Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence (2011)

Chapter:Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI

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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Appendix C

Recent and Ongoing Clinical
Trials: CRT for TBI

The following table includes recent and ongoing clinical trials related to cognitive rehabilitation therapy and traumatic brain injury; these trials may include criteria that go beyond the scope and methods used by the IOM committee in its evaluation of the current evidence. The trials are listed in alphabetical order, with start and end dates ranging from 1996 to 2013. The table was created based on information from ClinicalTrials.gov, a service of the National Institutes of Health (NIH).

Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
15 Year Longitudinal Study of TBI Incurred by Members of the Armed Forces in OIF/ OFF

Defense and Veterans Brain Injury Center

PI: COL Michael Lewis, M.D.
Phase 1: (Surveillance) DVBIC is collaborating with the Defense Manpower Data Center (DMDCJ to assess mortality surveillance of OIF/OEF veterans to determine whether an in-theatrc history of TBI increases risk of death among OIF/OEF veterans. DMDC obtains data from a variety of federal sources including information from the Social Security Administration's Death Master File and deceased benefit information from Veterans' Affairs. To date, DMDC has identified approximately 1.5 million service members who have served in OIF/OEF of which over 15,000 arc no lonecr alive as of March 2011.
Regarding those deaths, DVBIC is in the process of (a) determining cause of death; and (b) history of TBI. A series of statistical analyses will be performed on the data to identify possible trends within the data in an effort to determine factors that may have preventive benefit.
Phase 2: (Previous TBI Diagnosis) is submitting its protocol as an amendment to the Natural History protocol (Phase 3). Phase 2 is designed to collect ncurobchavioral information on service members and veterans who arc 12 months or more post-TBI diagnosis (dating back to October 2001), as well as trauma controls and healthy controls. Phase 2 includes a second protocol addressing health related quality of life in family caregivers of service members and veterans with TBI. The caregiver protocol will be submitted to OHSP for review last month.
Phase 3: (Incident TBI) has received approval for the Natural History protocol from the WRAMC and USUHS IRBs. Recruitment began at WRAMC in May 2011. The study is designed to collect comprehensive pathophysiologic, neurobehavioral, and ncuroimaging information on service members newly diagnosed with TBI, trauma controls, and healthy controls. Annual follow-up brief evaluations will be done and intermittently will include a comprehensive examination similar to baseline.
Acute Cognitive and Ncuro behavioral Intervention: Efficacy Evaluation Study Purpose: To learn more about behavior and everyday functioning after brain injury, and to learn if behavior and functioning gets better with more education about changes after brain injury.
Virginia Commonwealth University; U.S. Department of Education

PI: Jeffrey S. Kreutzer, Ph.D.
Detailed Description: To evaluate the efficacy of the First Steps intervention for improving neurobehavioral functioning, functional status, and life satisfaction, and for increasing knowledge about TBI and compensatory strategics. The First Steps program was developed to address the ncurobc-havioral and emotional concerns of survivors of TBI during the course of inpatient rehabilitation. Program format and content reflects clinical experience and extensive research review. Input from survivors, family members, and rehabilitation staff trained in working with the TBI population has also helped shape the implementation protocol. The foundation of the protocol is a curriculum [Nicmcicr, J., Krcutzer, J., &s Taylor, L.(2005). Acute cognitive and neurobchavioral intervention for individuals with acquired brain injury: Preliminary outcome data. Neuropsychological Rehabilitation, 15(2), 129-146.] The First Steps curriculum consists of 10 lessons and was developed to address the common needs, issues, and concerns of TBI survivors admitted acutely for inpatient rehabilitation.
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Sample Description Study Type Study Design Time Frame
Phase 1: All OIF/OEF Veteran Service Members since October 2001 Observational

•  Primary Purpose: Observational

2007 Start
Gender: Both
Group: Adult
Phase II: TBI :
N = 1,600
Tra Lima Controls:
N = 800
Healthy Controls:
N = 800
Gender: Both
Group: Adult
Phase III:
Focus Groups:
N = 60
Cognitive Interviews:
N = 60
Longitudinal Online
Questionnaire:
N = 300
Gender: Both
Group: Adult
N=103 Observational

•  Observational Model: Cohort



•  Time Perspective: Prospective

October 2002-
Octobcr2008
Gender: Both
Group: Adult/Senior
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
Acute Neurobehav-ioral Program for Improving Functional Status After TBI

Virginia Common wealth University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (N1CHD)

PI: Janet P. Niemeier, Ph.D.
Study Purpose: More than 1.4 million people a year in the United States begin confronting life with the medical, cognitive, and psychosocial challenges resulting from traumatic brain injury (TBI). A range of cognitive impairments commonly observed following injury increase caregiver burden as well as per-person lifetime costs for care and support of survivors of TBI, estimated at $600,000 to $1,875,000. Our long-term goal is to lessen these burdens through improving the functional status of patients with TBI by providing an evidence-based, comprehensive, brief, acute-care intervention, First Steps Acute Neurobehavioral and Cognitive Intervention (FANCI). The 10-sesson, manualized FANCI Program will be tested in a controlled, randomized study. Therapeutic components of the FANCI include didactics, cognitive remediation, demonstration, guided self-reflection, rehearsal, and supported practice of skills and strategies. Specific hypotheses are that (1) FANCI will result in more improvement in functional status compared to standard interdisciplinary rehabilitation treatment and (2) FANCI will result in more improvement on measures of neurobehavioral functioning compared to standard rehabilitation care for patients with moderate to severe TBI. We base these hypotheses on the observations that (1) providing information about symptoms, treatment, and coping results in reduced symptom intensity' and duration for patients with TBI, and (2) inpatient participants in recent FANCI pilot studies learned > 80% of the FANCI Program curriculum, and (3) the most recent pilot study participants had significantly better functional outcomes at discharge than matched controls. The specific aims of the proposed study are to (1) evaluate the efficacy of FANCI for improving functional status following treatment using the FIM, (2) examine the impact of FANCI on broader outcome measures of general emotional and behavioral functioning and productive activity in the community as measured post-treatment and at 6-month follow-up, (3) examine contributions of participant injury severity and cognitive status at time of treatment to treatment outcome and treatment response, (4) examine contributions of treatment variables of session topic and mastery, caregiver presence, and concurrent therapies on treatment outcome and treatment response for inpatients with TBI. Primary outcome measure is the (FIM). We will secondarily compare scores on the Disability Rating Scale (DRS), Glasgow Outcome Scale-Extended (GOSE), Rehabilitation Intensity of Therapy Scale (RITS), and Frontal Systems Behavior Scale (FRsBe). Our design is a parallel groups, single-blind, randomized, controlled trial. We will enroll 150 (75 treatment, 75 control) participants. Inclusion Criteria: Mod. to Sev. TBI based on time to commands, English speaker. Length of stay ≥ 5 days in acute BI rehabilitation Unit, 18 years of age or older, ≥ 79 on GOAT

Detailed Description: N/A
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Sample Description Study Type Study Design Time Frame
N= 150

Gender: Both

Group: Adult/Senior
Interventional

•  Allocation: Randomized


•  Control: Placebo Control


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Parallel Assignment


•  Masking: Double Blind (Investigator, Outcomes Assessor)


•  Primary Purpose: Treatment

March 2008-
September 2013
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
Amantadine for Treat ment of Symptoms of the Post-Traumatic Confusional State

Methodist Rehabilitation Center; U.S. Department of Education

PI: Stuart A. Yablon, M.D.
Study Purpose: Patients with traumatic brain injury often experience a period of acute confusion that may include agitation as they recover from their injuries. While this confusion generally resolves with time, patients may pose increased risk of injury to themselves or others during this period. Their behavior may also increase stress for family members and interfere with their ability to benefit from rehabilitation therapies. A number of different medications have been used to treat confusion to decrease agitation, decrease risk of injury, and improve participation in rehabilitation therapies. To this point, there has not been a research or scientific basis for knowing which medication is the best for a specific patient. The overall goal of this study is to conduct a scientific investigation to help determine which medication works best to treat confusion.

Detailed Description: Patients with TBI who require inpatient rehabilitation are frequently confused at the time of admission for rehabilitation. Our investigations of confusion conducted as part of the TBIMSM have clarified the nature of confusion in early recovery after TBI. Early confusion (PTCS) has been found to be a complex syndrome characterized by disorientation, cognitive impairment, restlessness, decreased level of daytime arousal, sleep disturbance, fluctuation of symptoms, and psychotic-type symptoms. PTCS complicates early management of patients with TBI, and may contribute to increased risk of injury to patients and hospital staff, increased stress among family members and staff, decreased participation in therapies, increased cost of care, and an increased likelihood of being discharged to psychiatric or long-term care settings. These facts indicate the need for effective management of PTCS. Consensus regarding optimal treatment of the cognitive and behavioral symptoms encountered among patients with PTCS does not exist currently. While many agents have been tried to address such symptoms in TBI, few have been investigated systematically. These circumstances indicate the need for appropriate clinical trials to provide guidance to clinicians for medical treatment of PTCS. In response, the NIDRR-Traumatic Brain Injury Model System of Mississippi proposed a randomized, double-blinded, placebo-controlled, parallel group trial for the pharmacological treatment of PTCS. The agent selected for this clinical trial is amantadine, an NMDA and indirect dopamine agonist. This agent will be compared to placebo on response measures of efficacy and safety. Study hypothesis: Amantadine will reduce the severity and number of symptoms of PTCS.
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Sample Description Study Type Study Design Time Frame
N= 79

Gender: Both

Group: child/Adult/Senior
Interventional

•  Allocation: Randomized


•  Control: Placebo Control


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Parallel Assignment


•  Masking: Double Blind (Investigator, Outcomes Assessor)


•  Primary Purpose: Treatment

April 2003-
June 2008
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
An Intervention Program to Reduce to the Risk of Persistent Symptoms After Concussion

University of British Columbia

PI: Noah Silverberg, Ph.D.
Study Purpose: This study investigates how well a new therapy program prevents persistent symptoms (e.g., headaches, fatigue, irritability, etc.) after concussion. The program involves examining beliefs about concussion and learning healthy coping strategies, and is completed with the first three months post-injury.

Detailed Description: Although the majority of patients with mild traumatic brain injury (MTBI) experience complete recovery within three months, a sizeable group continues to report frequent and severe symptoms such as headaches, fatigue, difficulty concentrating, forgetfulness, and irritability, in what is labeled persistent post-concussion syndrome (PCS). Persistent PCS is associated with vocational, recreational, and social disability. Early education and reassurance (treatment as usual) is effective in general, but appears insufficient for this subgroup. Recent research has identified risk factors for persistent PCS, including inaccurate illness beliefs, maladaptive coping behavior, and emotional distress. The present study will evaluate the additive efficacy of a cognitive-behavioral therapy protocol designed to modify these risk factors, over and above treatment as usual. Participants with MTBI will be recruited within 6 weeks of injury. Those identified as being at-risk for persistent PCS based on evidence-based criteria will receive treatment as usual and then be randomly assigned to receive either no further intervention or cognitive-behavioral therapy. We hypothesize that the group receiving cognitive-behavioral therapy will have fewer PCS symptoms and be less disabled at follow-up. We also hypothesize that compensation-seeking status will mitigate this improvement and that illness beliefs, coping behavior, and emotional distress will mediate this improvement. A blinded rater will conduct the baseline and outcome assessments.
Behavioral and Neuroimaging Changes After Cognitive Rehab in Traumatic Brain Injuries (TBI) and Mild Cognitive Impairment (MCI)

Department of Veterans Affairs; Emory University

PI: Benjamin M. Hampstead, Ph.D.
Study Purpose: Memory deficits are common after traumatic brain injuries (TBIs) and are characteristic of various forms of dementia, such as Alzheimer's disease and its common precursor mild cognitive impairment (MCI). This project intends to assess the efficacy of cognitive rehabilitation in these patient populations. We will also use neuroimaging (functional magnetic resonance imaging [fMRI]) to assess changes in brain activity that occurs following cognitive rehabilitation.

Detailed Description: N/A
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Sample Description Study Type Study Design Time Frame
N= 65

Gender: Both

Group: Adult
Interventional

•  Allocation:
Randomized


•  Control: Placebo
Control


•  Endpoint Classification:
Efficacy Study


•  Intervention Model:
Parallel Assignment


•  Masking: Double Blind (Investigator,
Outcomes Assessor)


•  Primary Purpose: Treatment

June 2009-April 2011
     
N= 60

Gender: Both

Group: Adult/Senior
Interventional

•  Allocation: Randomized


•  Control: Active Control


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Parallel Assignment


•  Masking: Single Blind(Subject)


•  Primary Purpose: Treatment

June 2008-June 2013
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
CDP-Choline and Working Memory After TBI: A Neuroim-aging Study

University of Pittsburgh; National Institutes of Health (NIH); Eunice Kennedy Shriver National Institute of Child Health and Human Development (KICHD)

PI: Patricia M. Arenth, Ph.D.
Study Purpose: The purpose of this study is to determine whether an investigational drug, called "CDP-Choline," improves memory in people with traumatic brain injury (TBI). To do this, we are asking for people with traumatic brain injury and people without traumatic brain injury to be a part of this study. We will compare results between each group to see if this investigational drug makes a difference with memory. We will also compare brain imaging results and information collected before and after the taking of the study medication to see if there are any differences. We hypothesize that there will be differences in brain activation patterns between individuals with TBI and healthy controls, as well as differences in performance on memory testing at baseline. We further hypothesize that, after treatment with CDP-Choline, the patterns in neuroimaging findings and cognitive testing results for individuals with TBI will more closely resemble results observed for healthy individuals. We hope that what we learn from this study will be helpful in the future treatment of individuals with head injury.

Detailed Description: Despite the prevalence of working memory deficits following traumatic brain injur)' (TBI), the scientific data regarding pharmacological treatment of this problem is limited- As deficits in working memory are known to have a significant impact on functional outcomes for individuals with TBI, further research in this area is essential in order for physicians to be able to treat this problem more effectively The primary goal of the proposed project is to examine the efficacy of a particular pharmacological agent, CDP-Choline, in the treatment of working memory deficits following traumatic brain injur)' (TBI). The study sample will consist of 48 subjects: A group of 24 individuals who have sustained moderate to severe TBI, and a group of 24 healthy controls. Each group will be divided into a placebo and treatment group. The project will utilize functional Magnetic Resonance Imaging (fMRI) to investigate the cerebral neurophysiological effects of treatment with CDP-Choline. A working memory task (N-Back) will be employed during fMRI sessions. In addition, the effects of treatment with CDP-Choline on neuropsychological testing performance will also be evaluated, and the correlations between behavioral performance and neuroimaging results will be observed. We will achieve these goals by comparing baseline neuropsychological testing results as well as fMRI results, with a second set of testing and neuroimaging results obtained following 1 month of pharmacological treatment with CDP Choline or placebo. Based on our preliminary studies and the available literature, we expect to see the following: Baseline fMRI results are expected to show that individuals with TBI display altered patterns of cerebral activation during a working memory task, as compared to healthy controls. With CDP-Choline treatment, we expect TBI subjects to display fMRI laterality and dispersion patterns that more closely resemble patterns of healthy controls. In addition, we anticipate improvements in behavioral performance on both the specific working memory task (N-Back), and on traditional neuropsychological tests to be associated with CDP-Choline treatment, with greater magnitude of change on testing results for the TBI group as compared to any changes noted for the control or placebo groups. Finally, we anticipate that specific significant correlations will be observed between neuropsychological testing results and neuroimaging findings, and that the strength of these relationships will be greater for the TBI treatment group, as compared to the placebo or healthy control groups. By conducting the proposed study in this manner, we hope to provide scientific data that will allow for improved treatment, and ultimately improved functional outcomes for individuals who have sustained TBI.
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Sample Description Study Type Study Design Time Frame
N= 48

Gender: Both

Group: Adult
Interventional

•  Allocation: Randomized


•  Control: Placebo Control


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Parallel Assignment


•  Masking: Double Blind (Investigator, Outcomes Assessor)


•  Primary Purpose: Treatment

March 2009-August2012
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI)

Department of Veterans Affairs

PI: Yelcna Bogdanova, Ph.D.
Study Purpose: The purpose of this study is to investigate the efficacy of a structured rehabilitation program on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).

Detailed Description: The most common impairments following blast-induced traumatic brain injury (bTBI) are cognitive deficits in the domain of executive functioning, learning and memory, and functional and psychosocial disabilities that are closely related to these cognitive deficits. There are no treatment protocols available to address the multiple cognitive impairments in bTBI, but cognitive rehabilitation has proven efficacious in the treatment of non-blast TBI. The cognitive training modules we plan to evaluate have improved organization and memory function in patients with non-blast TBI, but it is unknown whether their efficacy exceeds that of programs that focus only on education and support. This study is a between group comparison of a cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function, and an active control group receiving educational intervention geared at personal management of TBI-related symptoms.
Cognitive Therapy to Improve Word Finding

National Institute on Deafness and Other Communication Disorders (NIDCD)

PI: Rhonda B. Friedman, Ph.D.
Study Purpose: Adults who sustain brain damage due to stroke, traumatic injury or surgery may develop difficulty finding words. This study compares the effectiveness of two behavior-based programs to improve picture naming ability in these individuals.

Detailed Description: Difficulty finding words is common in patients with aphasia subsequent to left hemisphere stroke. This study will compare two cognitive therapies for the treatment of acquired word finding difficulties. The therapies use different types of cues. All participants will receive both therapies. Participants in this study will undergo a comprehensive and detailed assessment of language and other cognitive skills. The two treatments will be compared for their efficacy.
Early Rehabilitation of Patients with Posttraumatic Amnesia

University of Aarhus

PI: Jens Christian Sorensen, M.D., Ph.D.
Study Purpose: The purpose of this study is to investigate if a systematic intervention with early identifying of patients with posttraumatic amnesia using a reality orientation therapy can reduce the period with posttraumatic amnesia in order to get a better outcome for patients with traumatic brain injury.

Detailed Description: 1. A systematic review with the latest investigation and treatment of patients with posttraumatic amnesia, 2. Investigate the effect of a systematic nursing program on the length of posttraumatic amnesia, 3. Investigate the effect of a systematic nursing program after 12 month, 4. Describe perspectives for the future within the early rehabilitation of patients with posttraumatic amnesia.
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Sample Description Study Type Study Design Time Frame
N= 120

Gender: Both

Group: Adult
Interventional

•  Allocation: Randomized


•  Control: Placebo Control


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Parallel Assignment


•  Masking: Double Blind (Investigator, Outcomes Assessor)


•  Primary Purpose: Treatment

February 2011-September 2014
     
N= 40

Gender: Both

Group: Adult/Senior
Interventional

•  Allocation: Non-Randomized


•  Control: Uncontrolled


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Single Group Assignment


•  Masking: Open Label


•  Primary Purpose: Treatment

July 2004-June 2009
N= 62

Gender: Both

Group: Adult/Senior
Interventional

•  Allocation: Non-Randomized


•  Control: Active Control


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Single Group Assignment


•  Masking: Open Label


•  Primary Purpose: Supportive Care

September 2007-September 2010
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
Effect of Passive Gait Training on the Cortical Activity in Patients with Severe Traumatic Brain Injury

University of Aarhus; Aarhus County, Denmark

PI: Natallia Lapitskaya, M.D., Ph.D. (c)
Study Purpose: The aim of this study is to determine whether passive gait training increases arousal, demonstrated as changes in EEG (electroencephalogram) activity. Hypotheses: (1) Passive gait training increases EEG-frequency in patients with impaired consciousness due to severe traumatic brain injury. (2) Passive gait training increases conductivity speed of the cognitive P300-component of ERP in patients with impaired consciousness due to severe traumatic brain injury.

Detailed Description: Severe traumatic brain injury, especially after a high energy trauma, is characterized with focal lesions and diffuse axo-nal injury, which leads to the dysfunction in the cortico-spinal, cortico-cortical connections and reticular activation system. Formatio reticularis plays an important role in arousal. Tactile and proprioceptive stimulation with a view to improving level of consciousness in coma patients is popular in the western world despite insufficient evidence of its effectiveness. Affolter-Bobath-Coombes-concept is the most commonly used tool in the rehabilitation of brain damaged patients. This concept is based on the theory that tactile, proprioceptive and oral stimulation develops new connections in the brain and thereby stimulates consciousness and behavior. Elliot et al shows improvement in level of consciousness due to postural changes from a lying position to a standing posture in 8 of 12 patients using Wessex Head Injury Matrix. Passive movements result in proprioceptive stimulation; the effect of which is close to that achieved by physiological voluntary activity. PK 1 and fMRI studies show that passive movements activate several areas in the motor cortex. In order to increase afferent cortical input, passive gait training in the body weight support robotic gait orthosis could be used in patients with impaired consciousness, inability to cooperate and poor balance. This device gives the possibility to establish therapeutically correct upright body position and passive legs movement simultaneously. To our knowledge there are no studies, which illustrate the effects of passive gait training on cortical activity in patients with impaired consciousness due to severe traumatic brain injury. Our hypothesis is that passive gait training of this group of patients increases arousal, which can be shown in an increased EEG (electroencephalogram)-frequency and increased conductivity speed of the cognitive P300-component of ERP (Event Related Potentials). Comparison(s): EEG- and ERP-activity after a single training session in robotic gait orthosis in patients with severe traumatic brain injury, compared to EEG- and ERP-activity after a single training session in robotic gait orthosis in healthy persons.
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Sample Description Study Type Study Design Time Frame
N= 26

Gender: Both

Group: Adult/Senior
Interventional

•  Allocation: Non-Randomized


•  Control: Active Control


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Single Group Assignment


•  Masking: Open Label


•  Primary Purpose: Treatment

August 2006-August 2008
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
Efficacy of Pharmacological Treatment of Working Memory Impairment After Traumatic Brain Injury: Evaluation with fMRI

Kessler Foundation; University of Medicine and Dentistry New jersey; Cepbalon

PI: Elie P. Elovic, M.D.
Study Purpose: This study is designed to examine the effects of a wake-promoting agent (Modafinil) on working memory (WM) in persons with moderate to severe TBI utilizing a double blinded placebo controlled methodology. Our approach is to evaluate participants with BOLD fMRI and a limited neuropsychological battery to examine WM performance before and after pharmacological intervention.

Detailed Description: Work from our institution has shown that moderate and severe TBI subjects demonstrate an altered cerebral representation when they attempt to process a verbal WM task. Specifically, our data show a post-TBI pattern of activation that is dispersed and more lateralized to the right hemisphere, as compared to healthy controls. Taken together, we interpret these findings to mean that it is requires more cerebral resources for TBI subjects to process tasks that were previously more automatic. In other words, their processing is less efficient. This is consistent with TBI patients' self-reports of needing to expend greater cognitive effort to perform such tasks, both in the lab and in everyday life. Our preliminary data was the first step in understanding the cerebral substrate of these difficulties. However, simply indicating that individuals with TBI have a WM problem is not enough. The development of targeted interventions to ameliorate these deficits is the next step in the treatment process. The present proposal has important implications for TBI rehabilitation. One of the major goals of cognitive remediation is to help TBI patients learn new information more accurately and efficiently, and to improve their performance in activities of everyday life. Because WM impairments are so prevalent in TBI, the present study can help to shed light on potential treatment alternatives for these potentially devastating problems. In spite of the prevalence and popularity of cognitive remediation strategies and procedures, there remains little empirical support for their efficacy, and virtually no understanding of the underlying neurocognitive processes that facilitate intervention. The ability to develop a potentially efficacious treatment modality, which has a solid foundation, would be immensely beneficial.
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Sample Description Study Type Study Design Time Frame
N= 20

Gender: Both

Group: Adult
Interventional

•  Allocation: Randomized


•  Control: Placebo Control


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Parallel Assignment


•  Masking: Double Blind (Investigator, Outcomes Assessor)


•  Primary Purpose: Treatment

August 2003-December 2008
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
Evaluation of Outcome Measures for Patients Diagnosed with Traumatic Brain Injury

National Institutes of Health Clinical Center (CC); Department of Defense; Center for Neuroscience and Regenerative Medicine

PI: Leighton Chan, M.D., M.P.H.
Study Purpose: Background: Traumatic brain injury (TBI) is a significant injury in the Armed Forces, but it is also common in the general population. This condition poses significant challenges for both diagnosis and therapy. However, the biological and neurological reasons for TBI remain poorly understood and are in need of more in-depth study. The National Institutes of Health is collaborating with several military medical centers and research units in a multi-year study of TBI in civilian and military patients. In anticipation of these research projects, the Clinical Center’s Rehabilitation Medicine Department needs to become familiar with the instruments they will likely need to evaluate this group of subjects. Objectives: To evaluate potential test instruments in patients with TBI. To evaluate patient tolerance of an extensive battery of assessments and the time required to complete the assessments. To improve staff competencies on new or novel assessments of the TBI patient population. Eligibility: Individuals 18 years of age and older who have been diagnosed with a traumatic brain injury in the past 5 years. Healthy volunteers 18 years of age and older who have had no instances of significant head trauma. Design: This study requires approximately 3 days of outpatient or inpatient evaluation. Subjects will undergo cognitive and neuropsychological tests, physical assessments, speech and language evaluation, and balance testing. Tests will be given orally, in writing, and on computers. The testing will be done in blocks of 2 to 3 hours, with rest periods as needed. Subjects may undergo any or all of the following assessments and screening tools, as determined by the researchers: cognitive, quality of life, and functional assessments; speech, language, and swallowing assessments; and physical functional performance and environment assessments (including balance testing). Subjects will remain under the care of their own health care providers while participating in this study.

Detailed Description: The objective of this study is to evaluate potential test instruments in the traumatic brain injury (TBI) patient population. We will assess outcome measures that test neuropsychological, cognitive, communicative, and physical functional outcomes on up to 60 patients with TBI and 20 healthy volunteers. Our aims are to evaluate the appropriateness of specific tests for TBI as well as to test patient tolerance of an extensive battery of assessments and the time required to complete the assessments. We will also focus on improving staff competencies as they relate to new or novel assessments on the TBI patient population.
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Sample Description Study Type Study Design Time Frame
N = 80

Gender: Both

Group: Adult/Senior
Observational Time Perspective: Prospective October 2009- Unknown
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
Evaluation, Pathogenesis, and Outcomeof Subjects with or Suspected Traumatic Brain Injury

National Institute of Neurological Disorders and Stroke (NINDS); Center for Neuroscience and Rehabilitation Medicine (CNRM); Department of Defense; Henry Jackson Foundation

PI: Steven Warach, Ph.D.
Study Purpose: Background: Traumatic brain injury may have a range of effects, from severe and permanent disability to more subtle functional C609 that often go undetected during initial treatment. C598To improve treatments and therapies and to provide a uniform quality of care, researchers are interested in developing more standardized criteria for diagnosing and classifying different types of traumatic brain injury. By identifying imaging and other indicators immediately after the injury and during the initial treatment phrase, researchers hope to better understand the nature and effects of acute traumatic brain injury. Objectives: To study the MRI results of individuals who have recently had head injury and suspected traumatic brain injury. To study the natural evolution of traumatic brain injury for up to 3 months after head injury. Eligibility: Individuals at least 18 years of age who have been admitted to a hospital with a diagnosed or suspected traumatic brain injury within the past 48 hours. Design: Participants will have two 3-hour study visits: an initial visit (within 48 hours of head injury) and a follow-up visit 4 days later. Participants may be asked to have an optional 90-day follow-up. Each visit will involve blood samples, an MRI scan (approximately 30 minutes), and a series of tests to evaluate brain function. At the optional follow-up visit, participants will have blood samples, an MRI scan, and a general traumatic brain injury assessment. This study does not provide treatment and does not replace any current therapies. However, participants who are eligible for other National Institutes of Health studies may be referred to these studies by researchers.

Detailed Description: Objective: To generate natural history data for cohort-based comparisons to serve as the basis for future hypothesis-driven protocols and to contribute to the clinical and physiological understanding of traumatic brain injury (TBI) through the description of manifestations of the injury and the relationship among radiological, hematological, clinical variables and standard functional/cognitive outcome measures. Study Population: 300 male and female adult subjects with history of recent head injury with or suspected non-penetrating acute TBI, will be enrolled. Subjects having varying degrees of TBI severity will be recruited from the collaborative programs between NIH and non-NIH hospitals. We anticipate approximately 80% of subjects will be classified as mild TBI, concussion, or no injury, with approximately two thirds of those subjects enrolled being discharged directly from the emergency department. Design: This is a prospective cohort study of subjects with known and suspected non-penetrating acute traumatic brain injury. Subjects presenting to the emergency department or trauma service at participating hospitals with a history of recent head injury will be studied during the course of their hospital stay and after discharge using radiological, hematological, clinical and functional/cognitive outcome measures. Subjects will be stratified according to findings into cohorts for comparison. The design is intentionally broad in scope to allow acquisition of initial data for the development of future hypothesis-driven protocols. Research performed under this protocol will not interfere with standard of care and subjects will not be treated with experimental therapies as part of the research study. Data collected under this research study may be shared without personal identifiers with other researchers if subjects approve this option on the informed consent. Outcome Measures: A variety of outcome measures will be used including diagnosis, evidence of injury on magnetic resonance imaging (MRI), functional and cognitive impairment, and quality of life (QOL) assessments. The initial research questions will focus on a positive diagnosis of brain injury and monitoring the natural history. Statistical analysis plans will be developed as specific research questions and hypotheses are generated.
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Sample Description Study Type Study Design Time Frame
N = 300

Gender: Both

Group: Adult/Senior
Observational Time Perspective: Prospective May 2010- Unknown
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
Feasibility Study of Duloxetine in the Treatment of Depression in Patients with Traumatic Brain Injury (TBI)

Rehabilitation Hospital of Indiana; Eli Lilly and Company

PI: Lance Trexler, Ph.D.
Study Purpose: The primary objective of the study is to compare the efficacy of duloxetine 60 mg PO daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury (TBI) and to enhance cognitive function. Research exploring the use of selective serotonin reuptake inhibitors (SSRIs) in the treatment of post-traumatic depression generally validates this approach (Horsfield et al., 2002). However, the literature suggests that serotonin/norepinephrine reuptake inhibitors (SNRIs) such as duloxetine may be more effective in the treatment of depression.
Improving Executive Functioning After Traumatic Brain Injury (TBI): A Trial of the “Short Term Executive Plus” Program

Mount Sinai School of Medicine; Centers for Disease Control and Prevention

PI: Wayne Gordon, Ph.D.
Detailed Description: N/A

Study Purpose: The purpose of this study is to determine the efficacy of an intensive short term cognitive rehabilitation program aimed towards improving executive functioning in individuals with traumatic brain injury (TBI).

Detailed Description: Executive dysfunction following brain injur)* (BI) is commonly observed and has been well documented in the litera- ture (Matter, 1999; Prigatano, 1999; Lcvinc ct aL, 2000; Shallicc and Burgess, 1991; Cicerone and Giacino, 1992; Goldman-Rakic, 1993; Lczak, 199S; McDonald, 2002; Ricgal and Gauggcl, 2002; Stuss and Lcvinc, 2003). Level of functioning such as vocational success, com- munity reintegration, and social autonomy arc associated with executive functioning abilities following BI (Sohlbcrg, Matter, and Stuss, 1993; Mazaux ct al. 1997; McDonald, 2002; Stuss and Lcvinc, 2002). How- ever, studies describing the rehabilitation of executive dysfunction have been limited to mostly single case or small group designs {Cicerone ct al., 2000). However, there have been three small randomized clinical trials that have had promising results suggesting the need for more study needed in this area. When considering all of the studies it is evident that emphasis has been placed on three areas of intervention: attention reme- diation, emotional regulation and problem-solving. Consequently, given the pervasive disability found in individuals with BI that is secondary to executive function disorders and the promising, but limited, success of problcnvsolving-bascd interventions for executive functions, a random- ized controlled trial (RCT) of the efficacy of a short-term, intensive exec- utive function training program (Short-Term Executive Plus) is proposed. The Short-Term Executivt Plus (STEP) program will combine treatments and treatment approaches that have proven to be effective in previous studies and will be compared to "wait-list" control group. This design was chosen because no appropriate control intervention exists. In other words there is no "standard" rehabilitation treatment available to these individuals that could serve as an appropriate "control" condition/treat- ment. As discussed earlier, cognitive remediation is typically delivered in extended full-time day treatment programs or wcckly/bi-wcckly indi- vidual sessions. Using more traditional extended treatments as a control condition would be inappropriate, as persons who can participate in extended, full-time arc not the target of the proposed intervention. It is hypothesized that the STEP program will result in significant improve- ments in executive functioning (and related areas of attention, memory. community participation, and life satisfaction).
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Sample Description Study Type Study Design Time Frame
N = 44

Gender: Both

Group: Adult/Senior
Interventiona

•  Allocation: Randomized


•  Control: Placebo Control


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Parallel Assignment


•  Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


•  Primary Purpose: Treatment

September 1996- September 2012
N = 200

Gender: Both

Group: Adult
Interventional

•   Allocation: Randomized


•   Control: Placebo Control


•   Endpoint Classification: Efficacy Study


•   Intervention Model: Crossover


•   Assignment


•   Masking: Open Label


•   Primary Purpose: Treatment

January 2008- August 2012
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
Improving Executive Functions After Traumatic Brain Injury (TBI): A Clinical Trial of the “Executive Plus” Program

Mount Sinai School of Medicine; U.S. Department of Education

PI: Wayne A. Gordon, Ph.D.
Study Purpose: This is a randomized clinical trial which compares a standard day treatment program for individuals with TBI with the “Executive Plus” program; the latter emphasizes training of attention, emotional self-regulation and problem solving. The goal of the Executive Plus program is to maximize executive functioning, as well as the long-term outcomes of community participation and satisfaction with daily life.

Detailed Description: This is a randomized clinical trial comparing two approaches to post-TBI comprehensive day treatment. Executive Plus offers systematic treatment of post-TBI executive function deficits, through a focus on problem solving and emotional self-regulation, as well as systematic treatment of post-TBI attention deficits. It relies on modular, contextual, and embedded approaches to treatment. It will be compared to Mount Sinai’s currently operating day treatment program. The 26-week programs will run concurrently and potential participants will be randomly assigned to Executive Plus or the standard program, using rolling admissions. Program staffs will be separate. Outcomes will be assessed using measures that focus on functioning within cognitive domains, across domains and in everyday life, and that assess long-term outcomes. Detailed manuals will be developed to guide the implementation of each program’s operation.
Improving Work Outcomes for Veterans with Traumatic Brain Injury

Department of Defense

PI: Elizabeth W. Twamley, Ph.D.
Study Purpose: The 12-month study will investigate a cognitive training augmentation of supported employment to improve cognitive performance and work outcomes, which are expected to result in improved quality of life and community integration for veterans with mild to moderate traumatic brain injuries. The primary hypothesis is that compared to veterans who receive enhanced supported employment, those who receive supported employment plus cognitive training will work more weeks during the 12 months.

Detailed Description: N/A
Life Improvement Following Traumatic Brain Injury

University of Washington; National Institutes of Health (NIH); U.S. Department of Education

PIs: Jesse R. Fann, M.D., M.P.H., Charles H. Bombardier, Ph.D.
Study Purpose: Major Depressive Disorder (MDD) is the most prevalent psychiatric disorder in persons with traumatic brain injury (TBI) and is most common during the first several years after injury. MDD following TBI is associated with poor behavioral, health, and functional outcomes. While neurological factors contribute somewhat to the development of MDD in this population, there is evidence that numerous psychological, social and vocational factors also contribute. The investigators are conducting a three arm trial of Cognitive Behavioral Therapy (CBT) to treat Major Depression Disorder (MDD) that emerges within the first 10 years after complicated mild to severe traumatic brain injury (TBI). The overall objective of the study is to develop a 12-session telephone-based and in-person CBT program for people with TBI (CBT-TBI), and to evaluate its feasibility, acceptability, and effectiveness.

Detailed Description: N/A
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Sample Description Study Type Study Design Time Frame
N = 77

Gender: Both

Group: Adult/Senior
Interventional

•  Allocation: Randomized


•  Control: Active Control


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Parallel Assignment


•  Masking: Single Blind (Outcomes Assessor)


•  Primary Purpose: Treatment

October 2005- November 2010
N = 64

Gender: Both

Group: Adult/Senior
Interventional

•  Allocation: Randomized


•  Control: Active Control


•  Intervention Model: Parallel Assignment


•  Masking: Single Blind (Outcomes Assessor)


•  Primary Purpose: Treatment

September 2008- August 2011
N = 90

Gender: Both

Group: Adult/Senior
Interventional

•  Allocation: Randomized


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Parallel Assignment


•  Masking: Single Blind (Outcomes Assessor)


•  Primary Purpose: Treatment

September 2007- August 2012
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
Methylphenidate (Ritalin) and Memory/Attention in Traumatic Brain Injury (TBI)

Dartmouth-Hitchcock Medical Center; National Institutes of Health (NIH)

PI: Thomas W. McAllister, M.D.
Study Purpose: Traumatic brain injury (TBI) is a significant public health problem, with 1.5-2.0 million Americans injured each year. Cognitive deficits, particularly in the domains of memory and attention are frequently the source of lingering disability after TBI and a source of enormous distress to the injured individuals and their family/caregivers. To date, interventions to ameliorate chronic cognitive deficits have been directed at either pharmacological interventions or cognitive rehabilitation. We propose to (1) To compare the efficacy of three interventions: memory and attention training (MAAT), methylphenidate, and memory/attention training in combination with methylphenidate and (2) use functional MRI (fMRI) to characterize changes in activation of the neural circuitry of memory and attention due to MAAT alone, methylphenidate alone, and MAAT in combination with methylphenidate. This is a two by two design with medication (methylphenidate/placebo) and cognitive therapy (Memory and Attention Training [MAAT] or an attention control intervention) as possible interventions. Using a randomized, placebo-controlled, double-blind design, 200 individuals with persistent cognitive deficits 6-12 months after MTBI will be randomized to receive a six week trial of either (1) MAAT and placebo, (2) MAAT and methylphenidate (0.3 mg/kg BID), (3) attention control intervention and methylphenidate (0.3 mg/kg BID), or (4) attention control intervention and placebo. Symptom distress, attention and memory performance, and activation patterns of the neural circuitry of attention and memory while undergoing fMRI will be characterized at baseline, and after the four treatment conditions. This study will provide important information on three interventions for the most disabling sequelae of an enormous public health problem. Further, it will help to clarify underlying neural mechanisms and suggest additional treatment possibilities.

Detailed Description: What is known: There are two interventions of promising efficacy in ameliorating deficits in attention and memory after MTBI: (i) memory and attention training/rehabilitation, and (ii) catecholaminergic augmentation (particularly with methylphenidate, which augments both dopaminergic and adrenergic systems). fMRI and other functional imaging strategies are providing valuable insights into the underlying neural mechanisms of the cognitive enhancing effects of methylphenidate in some neuropsychiatric populations (individuals with ADHD), and the effects of cognitive rehabilitation efforts in some domains (e.g., speech and language in individuals after stroke). What is not known: To date there are no studies that apply a psychopharmacological strategy of augmenting neurotransmitter systems known to modulate memory/attention (dopaminergic and adrenergic systems) in combination with a cognitive rehabilitation intervention known to improve memory/attention (memory/attention training) in individuals with MTBI. We are aware of no published studies that use fMRI to assess the neural mechanisms of memory/attention improvement from the use of catecholaminergic agents or memory/attention training in individuals with MTBI. It is important to determine the efficacy of combined memory/attention training and methylphenidate. It is equally important to begin to understand the neural mechanisms underlying effective treatment as it may help to inform the development of the next generation of interventions and perhaps lead to individually tailored treatment interventions. This proposal will start to address these gaps in our knowledge.
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Sample Description Study Type Study Design Time Frame
N = 160 Gender: Both Group: Adult Interventional

•  Allocation: Randomized


•  Control: Placebo Control


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Factorial Assignment


•  Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


•  Primary Purpose: Treatment

February 2007- December 2012
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
Mindfulness-Based Cognitive Therapy Intervention to Treat Depression in Individuals with a Traumatic Brain Injury

Lakehead University; Ontario Neurotrauma Foundation

PI: Michel Bédard, Ph.D.
Study Purpose: The purpose of this study is to determine whether mindfulness-based cognitive therapy is effective in reducing depression symptoms in individuals who have experienced a traumatic brain injury. The investigators hypothesize that participants who are given the 10-week intervention will have fewer depression symptoms than the participants in the control group, and this improvement will be maintained at the 3-month follow-up assessment.

Detailed Description: Major depression is a significant chronic problem for people with traumatic brain injury (TBI), and its treatment is difficult. A promising approach to treat depression is mindfulness-based cognitive therapy (MBCT), a relatively new therapeutic approach rooted in mindfulness-based stress-reduction (MBSR) and cognitive behavioral therapy (CBT). This multi-site, randomized, controlled trial of a MBCT intervention will examine the value of this intervention in improving quality of life and decreasing depression in people with TBI. MBCT may represent a time-limited, cost-effective group intervention through which clinicians would have an opportunity to address some of the most debilitating aspects of TBI.
PC-Based Cognitive Rehabilitation for Traumatic Brain Injury (TBI)

Department of Veterans Affairs

PI: David L. Woods, Ph.D.
Study Purpose: The investigators will evaluate whether it is possible to improve memory and attention in patients who have suffered traumatic brain injury through the use of at-home computer training. Patients will be issued a computer and will train for three months on tasks that become more challenging as the subjects performance improves. The investigators will evaluate whether the training strengthened mental abilities in general, but evaluating mental abilities in the laboratory before and after testing.

Detailed Description: Here we propose two randomized clinical trials to determine if at-home PC-based adaptive training can improve cognitive function in chronic TBI patients. Both trials will use protocols designed to drive beneficial neuroplastic changes using paradigms similar to those that have shown promising results in smaller scale studies. The first experiment will investigate the effects of training of short-term verbal and spatial memory. Thirty-six patients with chronic mild, moderate and severe TBI will be evaluated with an extensive battery of neuropsychological tests (NPTs) and subjective rating scale measures at study entry. NPT and rating scale data will be compared to those obtained from 100 matched control subjects to characterize the cognitive deficits following mild, moderate and severe TBI. Patients will then be randomly assigned to immediate training (IT) or delayed training (DT) groups in a longitudinal crossover design. IT patients will begin training for 20 min/day on each of three different memory tasks for a period of three months. Training data will be automatically uploaded to monitor daily compliance and learning rate. NPT and rating scale assessments will be obtained midway through the study. Comparisons of changes in trained (IT) and untrained (DT) groups will be used to evaluate training efficacy. Then, during the second phase of the study, the DT group will undergo identical training. Repeat testing at the end of the study will quantify the effects of training on the DT group, and evaluate retention of training benefit in the IT group. The second experiment will evaluate the effects of training on attention and executive function using a similar randomized trial with a separate group of 36 chronic TBI patents. A comparison of the magnitude of training-related improvements in the two experiments will be used to evaluate specific and non-specific factors that contribute to training benefit and identify the patient characteristics that are most critical for successful cognitive rehabilitation.
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Sample Description Study Type Study Design Time Frame
N = 120

Gender: Both

Group: Adult/Senior
Interventional

•  Allocation: Randomized


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Crossover Assignment


•  Masking: Open Label


•  Primary Purpose: Treatment

March 2009- April 2010
N = 100

Gender: Both

Group: Adult
Interventional

•  Allocation: Randomized


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Crossover Assignment


•  Masking: Open Label


•  Primary Purpose: Treatment

July 2009- December 2012
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury

University of Texas Southwestern Medical Center; Baylor University

PI: Ramon R. Diaz-Arrastia, M.D., Ph.D.
Study Purpose: Growth Hormone (GH) deficiency, defined by insufficient GH response to a variety of stimulating compounds, is found in 20-35% of adults who suffer traumatic brain injuries (TBIs) requiring inpatient rehabilitation1. However, there is no accepted gold standard for diagnosing GH deficiency in this population. Further, the major effector molecule of the somatotropic axis, Insulin-Like Growth Factor-1 (IGF-1) has recently been recognized as an important neurotrophic agent. Since most repair and regeneration after TBI occurs within the first few months after injury, absolute or relative deficiencies of GH and IGF-1 in the subacute period after TBI are potentially important factors why some patients fail to make a good functional recovery. The proposed study is a randomized, double-blind, placebo-controlled trial of recombinant human Growth Hormone (rhGH), starting at 1 month post TBI, continuing for 6 months. This study has one primary hypothesis, that treatment with rhGH in the subacute period after TBI results in improved functional outcome 6 months after injury. As secondary hypotheses, we will investigate what is the optimal method to diagnose GH deficiency in TBI survivors and study the relationship between GH deficiency and insufficiency and functional recovery.

Detailed Description: N/A
Rehabilitation of Traumatic Brain Injury in Active Duty Military Personnel and Veterans

The Defense and Veterans Brain Injury Center; James A. Haley Veterans Administration Hospital; Hunter Holmes McGuire Veteran Affairs Medical Center; Minneapolis Veterans Affairs Medical Center; VA Palo Alto Health Care System; Department of Veterans Affairs

PIs: Deborah L. Warden, M.D., Elaine Date, M.D., Steven Scott, D.O., Barbara Sigford, M.D., Ph.D., William Walker, M.D.
Study Purpose: Context: Traumatic brain injury (TBI) is a common condition associated with significant long-term cognitive, behavioral, and functional morbidities. There are minimal controlled efficacy data of various acute rehabilitation intervention approaches. Objective: To determine the relative efficacy of two different acute TBI rehabilitation approaches-cognitive-didactic versus functional-experiential. Secondarily to determine relative efficacy for different patient subpopulations based on baseline cognitive functioning.

Detailed Description: A randomly assigned, intent-to-treat model of two different comprehensive treatment programs conducted between July 19 1996 and May 16, 2003 in 360 adult participants with moderate to severe TBI treated in four participating Veterans Administration TBI rehabilitation centers. All patients admitted to the Commission for Accreditation of Rehabilitation Facilities (CARF) accredited acute inpatient rehabilitation brain injury programs at four participating Veterans Administration Medical Centers (VAMCs) (Minneapolis, Palo Alto, Richmond, and Tampa) during the study enrollment period were screened for eligibility. The design was a randomized-controlled trial with two treatment arms (cognitive-didactic and functional-experiential), both embedded within an interdisciplinary TBI rehabilitation program. All treatment was hospital based. The interactive nature of the experimental conditions precluded subject blinding. Since each participating site serves a wide geographic area, the protocol permitted post-hospital outcome assessments by structured telephonic interview, to minimize drop out. Participants completed baseline assessment then received by random assignment one of the two standardized protocol rehabilitation programs (summarized below and described in detail elsewhere). Participants received 1.5 to 2.5 hours daily of protocol-specific therapy plus another 2 to 2.5 hours daily of occupational and physical therapy. Independent teams of therapists functioned at each site to deliver the separate treatments and by necessity were not blinded to treatment. Protocol monitoring site visits, biweekly conference calls, and biannual investigator meetings were conducted to ensure uniformity of protocol treatment over time.
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Sample Description Study Type Study Design Time Frame
N = 164

Gender: Both

Group: Adult
Interventional

•  Allocation: Randomized


•  Control: Placebo Control


•  Endpoint Classification: Safety/Efficacy Study


•  Intervention Model: Parallel Assignment


•  Masking: Double


•  Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


•  Primary Purpose: Treatment

September 2008- September 2012
N = 360

Gender: Both

Group: Adult/Senior
Interventional

•  Allocation: Randomized


•  Intervention Model: Parallel Assignment


•  Masking: Single Blind (Outcomes Assessor)


•  Primary Purpose: Supportive Care

July 1996-May 2003
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
Resuscitative Endocrinology: Single-Dose Clinical Uses for Estrogen-Traumatic Brain Injury

University of Texas Southwestern Medical Center

PI: Jane G. Wigginton, M.D.
Study Purpose: Each year in the United States alone, a third of a million persons are hospitalized for traumatic brain injury (TBI), of whom approximately one-quarter die. Most are less than 30 years of age. Not only are the health care costs staggering for both initial care and rehabilitation, but the societal loss in terms of economic impact reaches into the billions of dollars annually in the United States alone. Despite advances in neurosurgical interventions and intensive care management, many survivors do not fully recover. A significant cause of this mortality and morbidity is thought due to potentially preventable secondary injury, namely oxidant injury, inflammation, and apoptosis in the penumbra (the area of brain surrounding the primary lesion, which is at-risk, but potentially salvageable), beginning in the first few hours after the severe traumatic event. Despite the current bleak outlook for many of these patients, a series of animal investigations have uncovered a promising solution to the problem of the secondary injury seen in severe TBI and other similar processes, namely the early administration of estrogen, a strong anti-oxidant, anti-inflammatory and anti-apoptotic compound. Based on these encouraging results from animal studies, the investigators hypothesize that early administration of IV Premarin® in patients with severe TBI will safely reduce secondary brain injury, improve neurological outcomes, and improve survival.

Detailed Description: N/A
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Sample Description Study Type Study Design Time Frame
N = 50

Gender: Male

Group: Adult
Interventional

•  Allocation: Randomized


•  Control: Placebo Control


•  Endpoint Classification: Safety/Efficacy Study


•  Intervention Model: Parallel Assignment


•  Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


•  Primary Purpose: Treatment

July 2009- Unknown
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
Telerehabilitation for Operation Iraqi Freedom/ Operation Enduring Freedom (OIF/OEF) Returnees with Combat-Related Telerehab for Traumatic Brain Injury

Department of Veterans Affairs

PI: Kris Siddharthan, Ph.D.
Study Purpose: The scientific objective of this program is to meet the rehabilitation needs of combat wounded veterans with mild to moderate Traumatic Brain Injury (TBI) via telerehabilitation and determine the effect of this modality of care on patients’ physical health and outcomes including function and community participation. We will also evaluate the benefits and limitations of rehabilitation using telehealth from the veteran and caregiver perspectives and evaluate the impact of rehabilitation via telehealth on Veterans Administration (VA) healthcare facility use.

Detailed Description: Rational: TBI can cause life-long impairments in physical, cognitive, behavioral and social function that are usually more disabling than the residual physical deficits. Recovery can continue many years after initial trauma. Little is known about optimal methodologies to treat the vast and complicated secondary manifestations of combat-related TBI. Applicability: The goal of this rehabilitation program is eventually to optimally define telerehabilitation services for all veterans with polytrauma, including accurate and efficient screening instruments, educational material for patients and families, family support, and family counseling to enhance care coordination and to maximize functional outcomes and quality of life. Patient population: The program will help wounded veterans with a diagnosis of TBI from combat operations in Iraq and Afghanistan. Many veterans reside in rural and underserved areas. Although access to health care for rural patients remains a critical challenge, telerehabilitation may represent a viable means for the delivery of therapeutic services to such patients, particularly those served by the VA. The program has implications for civilian populations as well including those injured in automobile or industrial accidents and similar in illness to the cohort of veterans we intend to follow. Clinical applications, benefits and risks: The goals of the rehabilitation project will be to enhance the wounded veteran’s capacity to process and interpret information and to improve his ability to function in all aspects of family and community life. It will involve a combination of restorative training which focuses on improving a specific cognitive function and compensatory training which educates veterans on adapting to the presence of a cognitive deficit that may or may not be curable using singular one to one interventions as well as integrated interdisciplinary approaches to target multiple conditions. We see no risks involved in this clinical intervention. Projected time to achieve a consumer-related outcome: The results of the telerehabilitation project should immediately be available for dissemination throughout the VA. The VA has already committed itself to a nationwide rollout of similar telerehabilitation projects for wounded veterans. Hence, the findings should have immediate application in VA care for returnees from combat.
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Sample Description Study Type Study Design Time Frame
N = 85

Gender: Both

Group: Adult
Interventional

•  Control: Uncontrolled


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Single Group Assignment


•  Masking: Open Label


•  Primary Purpose: Treatment

July 2008-May 2012
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Study Title, Sponsor, and Principle Investigator Study Purpose and Detailed Description
The Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury (SCORE)

Brooke Army Medical Center; The Defense and Veterans Brain Injury Center; Henry M. Jackson Foundation for the Advancement of Military Medicine

PI: Douglas B. Cooper, Ph.D.
Study Purpose: The objective of this trial is to evaluate the effectiveness of cognitive rehabilitation in OIF/OEF service members with a history of mild traumatic brain injury and persistent (3-24 months post-injury) cognitive complaints. This is a prospective, randomized, control treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of mild traumatic brain injury and persistent (3-24 months post-injury) cognitive complaints. Subjects will be recruited from consecutive patient referrals to the TBI Service at SAMMC-North. Patients who meet eligibility criteria and consent to participate in the treatment trial will be randomly assigned to one of four, 6-week treatment arms of the study. Subjects will be evaluated prior to the start of treatment and 3, 6, 12, and 18 weeks following the initiation of the study. The total number of patients to be studied is 160 (maximum), which is approximately 20 patients per month.

Detailed Description: This is a prospective, randomized, control treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of mild traumatic brain injury (mTBI) and persistent (3-24 months post-injury) cognitive complaints. Subjects will be recruited from consecutive patient referrals to the TBI Service at SAMMC-North. Patients who meet eligibility criteria and consent to participate in the treatment trial will be randomly assigned to one of four, 6-week treatment arms of the study: 1. Psychoeducational control group; 2. Non-therapist directed, computerized cognitive rehabilitation; 3. Therapist-directed individualized cognitive rehabilitation; and 4. Integrated interdisciplinary cognitive rehabilitation combined with cognitive-behavioral psychotherapy. (Components of the treatment arms are described in detail in section 4.6; Research Design and Methods.) All subjects enrolled in the study will receive the standard of care in management of chronic post-concussive symptoms, consistent with the VA/DoD Clinical Practice Guidelines for the Management of Concussion/mild TBI (Barth et al., 2009), regardless of treatment assignment. The standard of care includes provision of patient education materials (adapted from existing studies to address more persistent rather than acute symptom management), regular scheduled follow-up with a medical provider every 3 weeks, and symptom-based treatment of post-concussive complaints (e.g., medication trials for headache and co-occurring psychiatric disorders, physical therapy for vestibular complaints, case management, and supportive counseling with social work for soldiers assigned to the Warriors-in-Transition Battalion). Study participants who are assigned to treatment arms 2, 3, or 4 will additionally receive manualized cognitive rehabilitation therapies during the 6-week treatment phase of the study. Cognitive rehabilitation treatment intensity (i.e., number of hours of treatment per week) will be matched for individuals assigned to treatment arms 2, 3, or 4. Participants assigned to the control treatment group (treatment arm 1) will be offered individualized cognitive rehabilitation therapy if their cognitive complaints do not abate following the completion of the 6-week treatment trial.

Study participants will be evaluated prior to the initiation of treatment, as well as at 3-weeks, 6-weeks, 12-weeks, and 18-weeks following the start of treatment. Study evaluators will be blind to treatment assignment. Pre-treatment baseline assessments and peri-/post-treatment outcome assessments will include demographic information, injury-related variables, self-report inventories, performance on neuropsychological testing, and functional status (e.g., work status; healthcare utilization). Detailed descriptions of the data to be collected including primary and secondary outcome measures, as well as co-variate measures can be found in section 4.8: Instrumentation.
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Sample Description Study Type Study Design Time Frame
N = 160

Gender: Both

Group: Adult
Interventional

•  Allocation: Randomized


•  Endpoint Classification: Efficacy Study


•  Intervention Model: Factorial Assignment


•  Masking: Double Blind (Subject, Outcomes Assessor)


•  Primary Purpose: Treatment

June 2011- August 2014
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Page305
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Page306
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Page307
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Page308
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Page309
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Page312
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Page316
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Page318
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Page319
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
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Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
×
Page323
Suggested Citation:"Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI." Institute of Medicine. 2011. Cognitive Rehabilitation Therapy for Traumatic Brain Injury: Evaluating the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/13220.
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Next: Appendix D: Biosketches of Committee Members and Staff »
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Traumatic brain injury (TBI) may affect 10 million people worldwide. It is considered the "signature wound" of the conflicts in Iraq and Afghanistan. These injuries result from a bump or blow to the head, or from external forces that cause the brain to move within the head, such as whiplash or exposure to blasts. TBI can cause an array of physical and mental health concerns and is a growing problem, particularly among soldiers and veterans because of repeated exposure to violent environments. One form of treatment for TBI is cognitive rehabilitation therapy (CRT), a patient-specific, goal-oriented approach to help patients increase their ability to process and interpret information. The Department of Defense asked the IOM to conduct a study to determine the effectiveness of CRT for treatment of TBI.

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