Cognitive Rehabilitation Therapy for Traumatic Brain Injury Evaluating the Evidence (2011) / Chapter Skim
Currently Skimming:
Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI
Appendix C: Recent and Ongoing Clinical Trials: CRT for TBI
Pages 287-324
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 287... ...
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.
|
From page 288... ...
Study Purpose: To learn more about behavior and everyday functioning Acute Cognitive and Neurobehavioral after brain injury, and to learn if behavior and functioning gets better Intervention: Efficacy with more education about changes after brain injury. Evaluation Detailed Description: To evaluate the efficacy of the First Steps interven tion for improving neurobehavioral functioning, functional status, and life Virginia satisfaction, and for increasing knowledge about TBI and compensatory Commonwealth strategies.
|
From page 289... ...
289 APPENDIX C Sample Description Study Type Study Design Time Frame Phase I: Observational • Primary Purpose: 2007 Start All OIF/OEF Veteran Observational Service Members since October 2001 Gender: Both Group: Adult Phase II: TBI: N = 1,600 Trauma 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 October 2002– Model: Cohort October 2008 Gender: Both • Time Perspective: Prospective Group: Adult/Senior
|
From page 290... ...
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.
|
From page 291... ...
291 APPENDIX C Sample Description Study Type Study Design Time Frame N = 150 Interventional • Allocation: March 2008– Randomized September 2013 Gender: Both • Control: Placebo Control Group: Adult/Senior • Endpoint Classification: Efficacy Study • Intervention Model: Parallel Assignment • Masking: Double Blind (Investigator, Outcomes Assessor) • Primary Purpose: Treatment
|
From page 292... ...
In response, the NIDRR-Traumatic Brain Injury Model System of Mississippi proposed a randomized, double-blinded, placebo-controlled, parallel group trial for the pharmacological treat ment of PTCS. The agent selected for this clinical trial is amantadine, an NMDA and indirect dopamine agonist.
|
From page 293... ...
293 APPENDIX C Sample Description Study Type Study Design Time Frame N = 79 Interventional • Allocation: April 2003– Randomized June 2008 Gender: Both • Control: Placebo Control Group: Child/Adult/ • Endpoint Senior Classification: Efficacy Study • Intervention Model: Parallel Assignment • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) • Primary Purpose: Treatment
|
From page 294... ...
A blinded rater will conduct the baseline and outcome assessments. Study Purpose: Memory deficits are common after traumatic brain injuBehavioral and Neuroimaging ries (TBIs)
|
From page 295... ...
295 APPENDIX C Sample Description Study Type Study Design Time Frame N = 65 Interventional • Allocation: June 2009–April Randomized 2011 Gender: Both • Control: Active Control Group: Adult • Endpoint Classification: Efficacy Study • Intervention Model: Parallel Assignment • Masking: Single Blind (Subject) • Primary Purpose: Prevention N = 60 Interventional • Allocation: Randomized July 2008–June • Control: Active 2013 Gender: Both Control • Endpoint Group: Adult/Senior Classification: Efficacy Study • Intervention Model: Parallel Assignment • Masking: Single Blind (Subject)
|
From page 296... ...
Ph.D. Detailed Description: Despite the prevalence of working memory deficits following traumatic brain injury (TBI)
|
From page 297... ...
297 APPENDIX C Sample Description Study Type Study Design Time Frame N = 48 Interventional • Allocation: March 2009– Randomized August 2012 Gender: Both • Control: Placebo Control Group: Adult • Endpoint Classification: Efficacy Study • Intervention Model: Parallel Assignment • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) • Primary Purpose: Treatment
|
From page 298... ...
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. Study Purpose: Adults who sustain brain damage due to stroke, trauCognitive Therapy to Improve Word Finding matic injury or surgery may develop difficulty finding words.
|
From page 299... ...
299 APPENDIX C Sample Description Study Type Study Design Time Frame N = 120 Interventional • Allocation: February 2011– Randomized September 2014 Gender: Both • Endpoint Classification: Group: Adult Efficacy Study • Intervention Model: Parallel Assignment • Masking: Open Label • Primary Purpose: Treatment N = 40 Interventional • Allocation: Non- July 2004–June Randomized 2009 Gender: Both • Control: Uncontrolled Group: Adult/Senior • Endpoint Classification: Efficacy Study • Intervention Model: Single Group Assignment • Masking: Open Label • Primary Purpose: Treatment N = 62 Interventional • Allocation: Non- September 2007– Randomized September 2010 Gender: Both • Control: Active Control Group: Adult/Senior • Endpoint Classification: Efficacy Study • Intervention Model: Single Group Assignment • Masking: Open Label • Primary Purpose: Supportive Care
|
From page 300... ...
Hypotheses: (1) Passive gait training increases with Severe Traumatic EEG-frequency in patients with impaired consciousness due to severe Brain Injury traumatic brain injury.
|
From page 301... ...
301 APPENDIX C Sample Description Study Type Study Design Time Frame N = 26 Interventional • Allocation: Non- August 2006– Randomized August 2008 Gender: Both • Control: Active Control Group: Adult/Senior • Endpoint Classification: Efficacy Study • Intervention Model: Single Group Assignment • Masking: Open Label • Primary Purpose: Treatment
|
From page 302... ...
in persons with of Working Memory moderate to severe TBI utilizing a double blinded placebo controlled Impairment After methodology. Our approach is to evaluate participants with BOLD fMRI Traumatic Brain and a limited neuropsychological battery to examine WM performance Injury: Evaluation before and after pharmacological intervention.
|
From page 303... ...
303 APPENDIX C Sample Description Study Type Study Design Time Frame N = 20 Interventional • Allocation: August 2003– Randomized December 2008 Gender: Both • Control: Placebo Control Group: Adult • Endpoint Classification: Efficacy Study • Intervention Model: Parallel Assignment • Masking: Double-Blind • Primary Purpose: Treatment
|
From page 304... ...
Detailed Description: The objective of this study is to evaluate potential test instruments in the traumatic brain injury (TBI) patient population.
|
From page 305... ...
305 APPENDIX C Sample Description Study Type Study Design Time Frame N = 80 Observational Time Perspective: October 2009– Prospective Unknown Gender: Both Group: Adult/Senior
|
From page 306... ...
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, clini cal variables and standard functional/cognitive outcome measures.
|
From page 307... ...
307 APPENDIX C Sample Description Study Type Study Design Time Frame N = 300 Observational Time Perspective: May 2010– Prospective Unknown Gender: Both Group: Adult/Senior
|
From page 308... ...
Detailed Description: N/A Study Purpose: The purpose of this study is to determine the efficacy of Improving Executive Functioning After an intensive short term cognitive rehabilitation program aimed towards Traumatic Brain Injury improving executive functioning in individuals with traumatic brain (TBI) : A Trial of the injury (TBI)
|
From page 309... ...
309 APPENDIX C Sample Description Study Type Study Design Time Frame N = 44 Interventional • Allocation: Randomized September 1996– • Control: Placebo Control September 2012 Gender: Both • Endpoint Classification: Efficacy Study Group: Adult/Senior • Intervention Model: Parallel Assignment • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) • Primary Purpose: Treatment N = 200 Interventional • Allocation: January 2008– Randomized August 2012 Gender: Both • Control: Placebo Control • Endpoint Classification: Group: Adult Efficacy Study • Intervention Model: Crossover • Assignment • Masking: Open Label • Primary Purpose: Treatment
|
From page 310... ...
Study Purpose: The 12-month study will investigate a cognitive training Improving Work Outcomes for Veterans augmentation of supported employment to improve cognitive perforwith Traumatic Brain mance and work outcomes, which are expected to result in improved Injury quality of life and community integration for veterans with mild to mod erate traumatic brain injuries. The primary hypothesis is that compared to veterans who receive enhanced supported employment, those who Department of Defense receive supported employment plus cognitive training will work more PI: Elizabeth W
|
From page 311... ...
• Primary Purpose: Treatment N = 90 Interventional • Allocation: September 2007– Randomized August 2012 Gender: Both • Endpoint Classification: Group: Adult/Senior Efficacy Study • Intervention Model: Parallel Assignment • Masking: Single Blind (Outcomes Assessor) • Primary Purpose: Treatment
|
From page 312... ...
in combination with a cognitive rehabilitation intervention known to improve memory/ attention (memory/attention training) in individuals with MTBI.
|
From page 313... ...
313 APPENDIX C Sample Description Study Type Study Design Time Frame N = 160 Interventional • Allocation: February 2007– Randomized December 2012 Gender: Both • Control: Placebo Control Group: Adult • Endpoint Classification: Efficacy Study • Intervention Model: Factorial Assignment • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) • Primary Purpose: Treatment
|
From page 314... ...
MBCT may represent a time-limited, cost-effective group intervention through which clinicians would have an opportunity to address some of the most debili tating aspects of TBI. Study Purpose: The investigators will evaluate whether it is possible to PC-Based Cognitive Rehabilitation for improve memory and attention in patients who have suffered traumatic Traumatic Brain Injury brain injury through the use of at-home computer training.
|
From page 315... ...
315 APPENDIX C Sample Description Study Type Study Design Time Frame N = 120 Interventional • Allocation: March 2009– Randomized April 2010 Gender: Both • Endpoint Classification: Group: Adult/Senior Efficacy Study • Intervention Model: Crossover Assignment • Masking: Open Label • Primary Purpose: Treatment N = 100 Interventional • Allocation: July 2009– Randomized December 2012 Gender: Both • Endpoint Classification: Group: Adult Efficacy Study • Intervention Model: Crossover Assignment • Masking: Open Label • Primary Purpose: Treatment
|
From page 316... ...
Detailed Description: N/A Study Purpose: Context: Traumatic brain injury (TBI) is a common Rehabilitation of Traumatic Brain Injury in condition associated with significant long-term cognitive, behavioral, Active Duty Military and functional morbidities.
|
From page 317... ...
317 APPENDIX C Sample Description Study Type Study Design Time Frame N = 164 Interventional • Allocation: September 2008– Randomized September 2012 Gender: Both • Control: Placebo Control Group: Adult • Endpoint Classification: Safety/Efficacy Study • Intervention Model: Parallel Assignment • Masking: Double • Blind (Subject, Caregiver, Investigator, Outcomes Assessor) • Primary Purpose: Treatment N = 360 Interventional • Allocation: July 1996–May Randomized 2003 Gender: Both • Intervention Model: Parallel Group: Adult/Senior Assignment • Masking: Single Blind (Outcomes Assessor)
|
From page 318... ...
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 neurologi cal outcomes, and improve survival. Detailed Description: N/A
|
From page 319... ...
319 APPENDIX C Sample Description Study Type Study Design Time Frame N = 50 Interventional • Allocation: July 2009– Randomized Unknown Gender: Male • Control: Placebo Control Group: Adult • Endpoint Classification: Safety/Efficacy Study • Intervention Model: Parallel Assignment • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) • Primary Purpose: Treatment
|
From page 320... ...
healthcare facility matic Brain Injury use. Detailed Description: Rational: TBI can cause life-long impairments in Department of physical, cognitive, behavioral and social function that are usually more Veterans Affairs disabling than the residual physical deficits.
|
From page 321... ...
321 APPENDIX C Sample Description Study Type Study Design Time Frame N = 85 Interventional • Control: July 2008–May Uncontrolled 2012 Gender: Both • Endpoint Classification: Group: Adult Efficacy Study • Intervention Model: Single Group Assignment • Masking: Open Label • Primary Purpose: Treatment
|
From page 322... ...
This is a prospective, randomized, control treatment trial of (SCORE) cognitive rehabilitation for OEF/OIF Service Members with a history of mild traumatic brain injury and persistent (3–24 months post-injury)
|
From page 323... ...
323 APPENDIX C Sample Description Study Type Study Design Time Frame N = 160 Interventional • Allocation: Randomized June 2011– • Endpoint Classification: August 2014 Gender: Both Efficacy Study • Intervention Model: Group: Adult Factorial Assignment • Masking: Double Blind (Subject, Outcomes Assessor) • Primary Purpose: Treatment
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.