Exploring the Adoption
of Implantable Brain
Stimulation into
Standard of Care for
Central Nervous System
Disorders
_____
Robert Pool, Eva Childers, and
Sheena M. Posey Norris, Rapporteurs
Forum on Neuroscience and
Nervous System Disorders
Board on Health Sciences Policy
Health and Medicine Division
Proceedings of a Workshop
NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
This activity was supported by contracts between the National Academy of Sciences and Acadia Pharmaceuticals; American Brain Coalition; American Neurological Association; Alzheimer’s Association; Boehringer Ingelheim; BrightFocus Foundation; California Institute for Regenerative Medicine; Cerevel Therapeutics; Cohen Veterans Bioscience; Dana Foundation; Department of Health and Human Services’ Food and Drug Administration (R13FD005362) and National Institutes of Health (NIH) (75N98019F00769 and 75N98024F00001 [Under Master Base HHSN263201800029I]) through the National Center for Complementary and Integrative Health, National Eye Institute, National Institute of Environmental Health Sciences, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, and NIH BRAIN Initiative; Department of Veterans Affairs (36C24E20C0009); Eisai Inc.; Foundation for the National Institutes of Health; Gatsby Charitable Foundation; Harmony Biosciences; Janssen Research & Development, LLC; Karuna Therapeutics; Lundbeck Research USA; Michael J. Fox Foundation for Parkinson’s Research; National Multiple Sclerosis Society; National Science Foundation (DBI-1839674); One Mind; Paul G. Allen Frontiers Group; Simons Foundation Autism Research Initiative; The George & Anne Ryan Institute for Neuroscience; University of Rhode Island; Takeda; and Wellcome Trust. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
International Standard Book Number-13: 978-0-309-71759-5
International Standard Book Number-10: 0-309-71759-0
Digital Object Identifier: https://doi.org/10.17226/27657
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2024. Exploring the adoption of implantable brain stimulation into standard of care for central nervous system disorders: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/27657.
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EXPLORING THE ADOPTION OF IMPLANTABLE BRAIN STIMULATION INTO STANDARD OF CARE FOR CENTRAL NERVOUS SYSTEM DISORDERS WORKSHOP PLANNING COMMITTEE1
TIM DENISON (Co-chair), University of Oxford; Amber Therapeutics Ltd.
HELEN MAYBERG (Co-chair), Icahn School of Medicine at Mount Sinai
NITA FARAHANY, Duke University
SARAH HOLLINGSWORTH LISANBY, National Institute of Mental Health
BRIAN LITT, University of Pennsylvania
LAURA LUBBERS, CURE Epilepsy
DAVID McMULLEN, U.S. Food and Drug Administration
JIM McNASBY, Michael J. Fox Foundation for Parkinson’s Research
MARTHA MORRELL, NeuroPace, Inc.
YAGNA PATHAK, Abbott Neuromodulation
SARAH PERIDES, Evelina London Children’s Hospital; Deep Brain Stimulation Nurse Association
RITA VALENTINO, National Institute on Drug Abuse
ALIK WIDGE, University of Minnesota
Health and Medicine Division Staff
SHEENA M. POSEY NORRIS, Director, Forum on Neuroscience and Nervous System Disorders
EVA CHILDERS, Program Officer
MAYA THIRKILL, Associate Program Officer (until July 2024)
EDEN NELEMAN, Senior Program Assistant (until August 2023)
KIMBERLY OGUN, Senior Program Assistant (starting October 2023)
CHRISTIE BELL, Senior Finance Business Partner
CLARE STROUD, Senior Director, Board on Health Sciences Policy
Consultant
ROBERT POOL, Science Writer
___________________
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, recommendations, and opinions expressed are those of individual presenters and participants; have not been endorsed or verified by the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine; and should not be construed as reflecting any group consensus.
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FORUM ON NEUROSCIENCE AND NERVOUS SYSTEM DISORDERS1
FRANCES JENSEN (Co-chair), University of Pennsylvania
JOHN KRYSTAL (Co-chair), Yale University
RITA BALICE-GORDON, Muna Therapeutics
DEANNA BARCH, Washington University in St. Louis
DIANE BOVENKAMP, BrightFocus Foundation
KATJA BROSE, The Chan Zuckerberg Initiative
TERESA BURACCHIO, U.S. Food and Drug Administration
SARAH CADDICK, The Gatsby Charitable Foundation
ROSA CANET-AVILÉS, California Institute for Regenerative Medicine
MARIA CARRILO, Alzheimer’s Association
MICHAEL CHIANG, National Eye Institute
TIMOTHY COETZEE, National Multiple Sclerosis Society
BEVERLY DAVIDSON, University of Pennsylvania
NITA FARAHANY, Duke University
EVA FELDMAN, University of Michigan
BRIAN FISKE, Michael J. Fox Foundation for Parkinson’s Research
JOSHUA A. GORDON, National Institute of Mental Health
MORTEN GRUNNET, Lundbeck
MAGALI HAAS, Cohen Veterans Bioscience
RICHARD J. HODES, National Institute on Aging
STUART W. HOFFMAN, Department of Veterans Affairs
YASMIN HURD, Icahn School of Medicine at Mount Sinai
STEVEN E. HYMAN, The Broad Institute of MIT and Harvard
MICHAEL IRIZARRY, Eisai Inc.
GEORGE KOOB, National Institute on Alcohol Abuse and Alcoholism
WALTER KOROSHETZ, National Institute of Neurological Disorders and Stroke
ROBERT MALENKA, Stanford University
HUSSEINI MANJI, Oxford University; Duke University; UK Government Mental Health
HUGH MARSTON, Boehringer Ingelheim
BILL MARTIN, The Janssen Pharmaceutical Companies of Johnson & Johnson
CAROLINE MONTOJO, Dana Foundation
JOHN NGAI, NIH BRAIN Initiative
GENTRY PATRICK, University of California, San Diego
STEVE MARC PAUL, Karuna Therapeutics, Inc. (until March 2024)
___________________
1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.
KATHRYN RICHMOND, Allen Institute
MARSIE ROSS, Harmony Biosciences
M. ELIZABETH ROSS, American Neurological Association
KATIE SALE, American Brain Coalition
RAYMOND SANCHEZ, Cerevel Therapeutics
TERRENCE SEJNOWSKI, Salk Institute for Biological Studies
SARAH SHEIKH, Takeda
SARA SHNIDER, One Mind
DAVID SHURTLEFF, National Center for Complementary and Integrative Health
JOHN SPIRO, Simons Foundation
ALESSIO TRAVAGLIA, Foundation for the National Institutes of Health
NORA VOLKOW, National Institute on Drug Abuse
DOUG WILLIAMSON, Acadia Pharmaceuticals (until April 2024)
RICHARD WOYCHIK, National Institute of Environmental Health Sciences
STEVIN ZORN, MindImmune Therapeutics, Inc.
Reviewers
This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.
We thank the following individuals for their review of this proceedings:
RACHEL A. DAVIS, University of Colorado Anschutz Medical Campus
HENRY T. GREELY, Stanford University
KAI KADOICH, U.S. Food and Drug Administration
JIM McNASBY, Michael J. Fox Foundation for Parkinson’s Research
SARAH PERIDES, Evelina London Children’s Hospital; Deep Brain Stimulation Nurse Association
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by ERIC LARSON, University of Washington. He was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.
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Contents
Organization of the Proceedings
2 CROSSING THE CHASM: LESSONS LEARNED ACROSS MEDICAL TECHNOLOGIES
The Adoption Curve of Medical Technologies
Setting the Stage: A Vision for Neuromodulation Technology
Lessons Learned Across Therapeutic Areas
3 PERSPECTIVES FROM THOSE WITH LIVED EXPERIENCES
A Disappointing Experience with the Treatment of Epilepsy
Successful Treatment of Parkinson’s Disease
Life-Changing Results in Treating Depression
Patient Selection in the United Kingdom’s National Health Service
Barriers to Receiving Deep Brain Stimulation
Helping Patients Decide Whether to Have Deep Brain Stimulation Surgery
Programming Deep Brain Stimulation Implants to Improve Outcomes
5 HEALTH PROFESSIONAL EDUCATION AND ADOPTION
Factors Influencing Clinician Adoption of Technologies
A Nurse Practitioner’s Perspective
Using Big Data to Improve Treatment
Barriers to the Adoption of Deep Brain Stimulation Technologies
6 REIMBURSEMENT AND OTHER ECONOMIC CONSIDERATIONS
Coverage Decisions at the Centers for Medicare & Medicaid Services
The Adoption of Deep Brain Stimulation Techniques
7 POTENTIAL NEXT STEPS TO MOVE THE FIELD FORWARD
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Acronyms and Abbreviations
| AI | artificial intelligence |
| CDRH | Center for Devices and Radiological Health |
| CMS | Centers for Medicare & Medicaid Services |
| DBS | deep brain stimulation |
| EEG | electroencephalogram |
| EHR | electronic health record |
| FDA | U.S. Food and Drug Administration |
| MDD | major depressive disorder |
| OCD | obsessive-compulsive disorder |
| RNS | responsive neurostimulation |
| TAP | Total Product Life Cycle Advisory Program |
| UPHS | University of Pennsylvania Health Systems |
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