Exploring the Adoption of Implantable Brain Stimulation into Standard of Care for Central Nervous System Disorders / Search Inside This Book
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... Introduction and Background1...
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... its ability to intervene directly in pathological neural circuits, implantable brain stimulation has had a profound impact on neuroscience research and, for several central nervous system (CNS) disorders, clinical care. Implantable brain stimulation is a therapy that involves a surgery in which a ... is implanted that sends electrical signals to designated brain areas such as deep brain stimulation (DBS)2 or responsive neurostimulation.3 In 1997 and 2002, the U.S. Food and Drug Administration (FDA) approved the use of implantable brain stimulation, specifically DBS, for the treatment of essential ... and Parkinson’s disease, respectively.4 Since then, the number of publications in the implantable brain stimulation field has increased rapidly and the technology has become a viable treatment option for various CNS disorders in addition to Parkinson’s disease, tremor,...
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... 1 The planning committee’s role was limited to planning the workshop, and the Proceedings of a Workshop was prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, ... , and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, and they should not be construed as ...
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... 2 For more information on DBS, see https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/deep-brain-stimulation (accessed January 23, 2024)....
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... 4 For more information on the history of DBS and regulatory approvals, see https://www.ninds.nih.gov/about-ninds/what-we-do/impact/ninds-contributions-approved-therapies/deep-brain-stimulation-dbs- ... -parkinsons-disease-and-other-movement-disorders (accessed February 26, 2024)....
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... dystonia, epilepsy, and obsessive-compulsive disorder (OCD) (Krauss et al., 2021; Lozano and Lipsman, 2013). Despite this growth, however, there remain unanswered questions about how implantable brain stimulation can be integrated into the ...
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... To date, implantable brain stimulation has been most integrated into the standard of care for Parkinson’s disease, as it is used regularly to relieve symptoms such as tremor, on-off fluctuations, and dyskinesia. It works by ... the basal ganglia, which can result in an altered basal ganglion neuron firing rate and pattern, increased calcium and neurotransmitter release, and increased blood flow and neurogenesis (Lee et al., 2004; Tawfik et al., 2010; Wichmann et al., 2011). However, it is unclear how these stimulation ...
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... Despite FDA approval via a humanitarian device exemption for the use of DBS in OCD and promising research in other psychiatric disorders, the use of implantable brain stimulation lags significantly behind other therapeutics. Barriers ... for psychiatric disorders include limitations in the current knowledge of the neural circuitry underlying these disorders, a lack of understanding of which physiologic changes from implantable brain stimulation are beneficial for which mental illnesses, and a need to identify which approaches ... most appropriate for various subgroups of patients (Bilge et al., 2018; Holtzheimer and Mayberg, 2011). There is also a lack of coverage by private insurers for FDA-approved psychiatric indications that can restrict patient access to the ...
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... For Parkinson’s disease, essential tremor, epilepsy, and psychiatric disorders, a number of challenges preclude the widespread adoption of implantable brain stimulation. One such challenge will be finding ... to making the technology scalable and sustainable. For example, the neurosurgery required to implant a brain stimulation device, coupled with the device’s maintenance, are expensive and ... ; Vedam-Mai et al., 2021). If implantable brain stimulation is to be adopted into routine clinical care, addressing barriers such as reimbursement and accessibility may be important to ensure widespread patient adoption....
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... Both patient and physician engagement play an important role in advancing the use of implantable brain stimulation in clinical care. In a recent study, a survey ... among patients with Parkinson’s disease found that while patients had reliable knowledge of the procedure and potential side effects, there were still common misconceptions such as believing that implantable brain stimulation would alter the natural course of ... disease (Chitnis et al., 2023). Unfortunately, patients who have heard of and are interested in implantable brain stimulation often report feeling...
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..., perhaps because of clinicians’ perception that these technologies are a “last resort” (Borovečki et al., 2023; Lökk, 2011). This perception and a lack of physician and patient education can have ethical implications on patient selection, expectations, and consent (Schermer, 2011)....
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... implantable brain stimulation’s increased use in clinical care, there remain unaddressed barriers to fully adopting this technology into the standard of care for CNS disorders. To better understand the current state of clinical use of the technology as well as patient and physician education and ... considerations related to the technology, on October 31, 2023, the Forum on Neuroscience and Nervous System Disorders of the National Academies of Sciences, Engineering, and Medicine held a workshop, Exploring the Adoption of Implantable ... Stimulation into Standard of Care for Central Nervous System Disorders.5 Participants included clinicians and clinical researchers interested in the use of implantable brain stimulation to treat CNS disorders, several individuals who had differing experiences ... implantable brain stimulation, representatives from federal regulatory and funding agencies, officers of advocacy organizations and health systems, and innovators and executives from companies that manufacture implantable devices for treating CNS disorders. Given that implantable brain stimulation is ... used for movement disorders, a larger portion of the workshop and this proceedings focused on lessons learned from this disease space, which may be useful to other CNS disorders moving forward....
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... Tim Denison, a professor of engineering science and clinical neurosciences at Oxford University and co-founder and chief scientific officer of Amber Therapeutics Ltd., described the workshop objectives in his introductory comments. The overall objective was to ... the current state of implantable brain stimulation in the treatment of CNS disorders, the current barriers to adopting this technology into standard of care, and opportunities for scalable utility in the future (see Box 1-1). More specifically, the workshop examined various barriers to the ... adoption of implantable brain stimulation and what would be required to overcome these barriers. Denison identified four areas in which barriers may exist: (1) clinical necessity and including ... lived experience throughout the design process to create solutions and treatments that will improve patient’s lives...
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... more about the workshop, see https://www.nationalacademies.org/event/40129_10-2023_exploring-the-adoption-of-implantable-brain-stimulation-into-standard-of-care-for-central-nervous-system-disorders-a-workshop (accessed November 26, 2023)....
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... in a meaningful way, (2) regulatory pathways, (3) workflow viability that considers what clinicians need to adopt new technology, and (4) economic viability that examines what pathways and incentives are necessary to scale this technology....
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... This proceedings summarizes the presentations and discussions from the workshop (see Appendix B for the workshop agenda)....
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... Chapter 2 reviews the current state of knowledge regarding the clinical use of implantable brain stimulation for several CNS disorders and discusses lessons learned from approved neuromodulation therapies, cochlear and retinal implants, responsive neurostimulation for epilepsy, and DBS ... OCD. Particular attention was paid to the issue of “crossing the chasm,” that is, moving a technology from pilot research and early adopters to mainstream clinical practice. Chapter 3 offers a firsthand look at the experiences of people with various disorders that ... brain stimulation can address, with the goal of keeping patients at the center of efforts to expand the adoption of this technology....
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... The next three chapters examine numerous practical barriers to the acceptance of implantable brain stimulation as standard of care. Chapter 4 examines issues related to patient selection and engagement that may hinder increased adoption. Chapter 5 focuses on the roles ... professional education and other factors play in leading clinicians to adopt new technologies or existing technologies for different roles. Chapter 6 explores how reimbursement ...
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... Finally, Chapter 7 reviews the key points individual speakers made during the workshop and highlights potential next steps for moving the field forward. The references list includes all sources mentioned in Chapters 1–7, and the workshop ...
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... A planning committee of the National Academies of Sciences, Engineering, and Medicine will organize and conduct a 1-day public workshop that brings together experts and key partners from academia, industry, government, philanthropic foundations, and ... stimulation to treat central nervous system (CNS) disorders. The workshop will explore barriers to adopting implantable brain stimulation into the standard of care across CNS disorders and potential strategies and collaborations to develop sustainable and scalable utility in the future....
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... Invited presentations and discussions may:...
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... Review the current state of knowledge regarding the clinical utilization of implantable brain stimulation across various CNS disorders and consider the future potential to improve quality of life for patients....
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... Explore barriers and potential solutions to adopting implantable brain stimulation into standard of care, such as safety and efficacy, scalability, and regulatory support....
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... Discuss the ethical and equity implications associated with reimbursement practices, accessibility, and technological distribution....
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... Examine opportunities to enhance health professionals and patient education to ensure informed access to implantable brain stimulation....
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... The planning committee will develop the agenda for the workshop, select and invite speakers and discussants, and moderate the discussions. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in ...
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