NON-INVASIVE
NEUROMODULATION
OF THE CENTRAL
NERVOUS SYSTEM
Opportunities and Challenges
WORKSHOP SUMMARY
Lisa Bain, Sheena Posey Norris, and Clare Stroud, Rapporteurs
Forum on Neuroscience and
Nervous System Disorders
Board on Health Sciences Policy
Institute of Medicine
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, NW • Washington, DC 20001
This project was supported by contracts between the National Academy of Sciences and the Alzheimer’s Association; Brain Canada Foundation; the Department of Health and Human Services’ Food and Drug Administration and National Institutes of Health (NIH, Contract No. HHSN26300026 [Under Master Base #DHHS-10001292]) through the National Center for Complementary and Integrative Health, National Eye Institute, 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 Blueprint for Neuroscience Research; Department of Veterans Affairs (VA240-14-C-0057); Eli Lilly and Company; Foundation for the National Institutes of Health; the Gatsby Charitable Foundation; GlaxoSmithKline, Inc.; Johnson & Johnson Pharmaceutical Research and Development, LLC; Lundbeck Research USA; Merck Research Laboratories; The Michael J. Fox Foundation for Parkinson’s Research; the National Multiple Sclerosis Society; the National Science Foundation (BCS-1064270); One Mind for Research; Orion Bionetworks; Pfizer Inc.; Pharmaceutical Product Development, LLC; Sanofi; the Society for Neuroscience; Takeda Pharmaceutical Company Limited; 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 this project.
International Standard Book Number-13: 978-0-309-37618-1
International Standard Book Number-10: 0-309-37618-1
DOI: 10.17226/21767
Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.
Copyright 2015 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2015. Non-invasive neuromodulation of the central nervous system: Opportunities and challenges: Workshop summary. Washington, DC: The National Academies Press.
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PLANNING COMMITTEE ON NON-INVASIVE NEUROMODULATION OF THE CENTRAL NERVOUS SYSTEM1
HANK GREELY (Co-Chair), Stanford University
JEFFREY NYE (Co-Chair), Johnson & Johnson Innovation
ALVARO PASCUAL-LEONE (Co-Chair), Harvard Medical School
STEPHEN BRANNAN, Takeda Pharmaceuticals International, Inc.
MARTHA FARAH, University of Pennsylvania
THOMAS INSEL, National Institute of Mental Health
DANIEL JAVITT, Columbia University
FRANCES JENSEN, University of Pennsylvania
WALTER KOROSHETZ, National Institute of Neurological Disorders and Stroke
JAY KRANZLER, Pfizer Inc.
VICTOR KRAUTHAMER, Food and Drug Administration
ANNE LOUISE OAKLANDER, Massachusetts General Hospital
CARLOS PEÑA, Food and Drug Administration
PETER REINER, University of British Columbia
RHONDA ROBINSON-BEALE, Blue Cross of Idaho
JUSTIN SANCHEZ, Defense Advanced Research Projects Agency
ROGER SORENSON, National Institute on Drug Abuse
IOM Staff
CLARE STROUD, Project Director
SHEENA M. POSEY NORRIS, Associate Program Officer
SOPHIE YANG, Senior Program Assistant
ANDREW M. POPE, Director, Board on Health Sciences Policy
__________________
1Institute of Medicine planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.
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FORUM ON NEUROSCIENCE AND NERVOUS SYSTEM DISORDERS1
STEVEN HYMAN (Chair), The Broad Institute of Massachusetts Institute of Technology and Harvard University
STORY LANDIS (Vice Chair), Former Director, National Institute of Neurological Disorders and Stroke
SUSAN AMARA, Society for Neuroscience
STEPHEN BRANNAN, Takeda Pharmaceuticals International, Inc.
KATJA BROSE, Cell Press
DANIEL BURCH, Pharmaceutical Product Development, LLC
SARAH CADDICK, Gatsby Charitable Foundation
ROSA CANET-AVILES, Foundation for the National Institutes of Health
MARIA CARRILLO, Alzheimer’s Association
C. THOMAS CASKEY, Baylor College of Medicine
KAREN CHANDROSS, Sanofi US
TIMOTHY COETZEE, National Multiple Sclerosis Society
FAY LOMAX COOK, National Science Foundation
WILLIAM DUNN, Food and Drug Administration
EMMELINE EDWARDS, National Center for Complementary and Integrative Health
MARTHA FARAH, University of Pennsylvania
DANIEL GESCHWIND, University of California, Los Angeles
HANK GREELY, Stanford University
MAGALI HAAS, Orion Bionetworks
RAMONA HICKS, One Mind for Research
RICHARD HODES, National Institute on Aging
STUART HOFFMAN, U.S. Department of Veterans Affairs
THOMAS INSEL, National Institute of Mental Health
PHILIP IREDALE, Pfizer Global Research and Development
JOHN ISAAC, Wellcome Trust
INEZ JABALPURWALA, Brain Canada Foundation
FRANCES JENSEN, University of Pennsylvania School of Medicine
GEORGE KOOB, National Institute on Alcohol Abuse and Alcoholism
__________________
1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.
WALTER KOROSHETZ, National Institute of Neurological Disorders and Stroke
ALAN LESHNER, American Association for the Advancement of Science (Emeritus)
HUSSEINI MANJI, Johnson & Johnson Pharmaceutical Research and Development, LLC
DAVID MICHELSON, Merck Research Laboratories
RICHARD MOHS, Lilly Research Laboratories
JAMES OLDS, National Science Foundation
ATUL PANDE, Tal Medical
STEVEN PAUL, Weill Cornell Medical College
TODD SHERER, The Michael J. Fox Foundation for Parkinson’s Research
DAVID SHURTLEFF, National Center for Complementary and Integrative Health
PAUL SIEVING, National Eye Institute
NORA VOLKOW, National Institute on Drug Abuse
STEVIN ZORN, Lundbeck Research USA
IOM Staff
BRUCE M. ALTEVOGT, Forum Co-Director (until May 2015)
CLARE STROUD, Forum Co-Director
SHEENA M. POSEY NORRIS, Associate Program Officer
ANNALYN M. WELP, Senior Program Assistant
ANDREW M. POPE, Director, Board on Health Sciences Policy
Reviewers
This workshop summary has been 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 institution in making its published workshop summary as sound as possible and to ensure that the workshop summary meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this workshop summary:
ROY HAMILTON, University of Pennsylvania School of Medicine
SARAH H. LISANBY, Duke University School of Medicine
ANA MAIQUES, Neuroelectrics
HANNAH MASLEN, University of Oxford
ABRAHAM ZANGEN, Ben Gurion University
MURRAY L. ZUCKER, United Behavioral Health
Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop summary before its release. The review of this workshop summary was overseen by ERIC B. LARSON, Group Health Research Institute. He was responsible for making certain that an independent examination of this workshop summary was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this workshop summary rests entirely with the rapporteurs and the institution.
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Contents
2 Overview of Gaps, Challenges, and Potential Opportunities
Potential Research Opportunities
Policy Issues and Potential Opportunities
3 The Science and Technology of Non-Invasive Neuromodulation
Targets and Mechanisms of Action
Neurostimulation Effects on the Brain
Non-Invasive Neuromodulation in Children
Modeling Electrical Dose and Exposure
Preclinical Studies in Animal Models
5 Using Non-Invasive Neuromodulation for Diagnosis and Research
Neuromodulation as a Research Tool
6 Enhancement of Brain Function and Performance
7 Ethical, Legal, and Social Issues
Freedom/Coercion/Involuntary Use
Regulatory Oversight for Over-the-Counter Use
Improving the Evidence Base for Reimbursement