Based on advances in biotechnology and neuroscience, non-invasive neuromodulation devices are poised to gain clinical importance in the coming years and to be of increasing interest to patients, clinicians, health systems, payers, and industry. Evidence suggests that both therapeutic and non-therapeutic applications of non-invasive neuromodulation will continue to expand in coming years, particularly for indications where treatments are currently insufficient, such as drug-resistant depression.

Given the growing interest in non-invasive neuromodulation technologies, the Institute of Medicine's Forum on Neuroscience and Nervous System Disorders convened a workshop, inviting a range of stakeholders - including developers of devices and new technologies, researchers, clinicians, ethicists, regulators, and payers - to explore the opportunities, challenges, and ethical questions surrounding the development, regulation, and reimbursement of these devices for the treatment of nervous system disorders as well as for non-therapeutic uses, including cognitive and functional enhancement. This report highlights the presentation and discussion of the workshop.

Contents

• The National Academies of SCIENCES • ENGINEERING • MEDICINE
• PLANNING COMMITTEE ON NON-INVASIVE NEUROMODULATION OF THE CENTRAL NERVOUS SYSTEM
• FORUM ON NEUROSCIENCE AND NERVOUS SYSTEM DISORDERS
• Reviewers
• 1. Introduction
  • ORGANIZATION OF REPORT
• 2. Overview of Gaps, Challenges, and Potential Opportunities
  • RESEARCH GAPS AND CHALLENGES
  • 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
  • ELECTROMAGNETIC DEVICES
  • ULTRASOUND
  • PRECLINICAL STUDIES IN ANIMAL MODELS
• 4. Therapeutic Uses of Non-Invasive Neuromodulation
  • PSYCHIATRIC DISORDERS
  • NEUROREHABILITATION
  • OTHER NEUROLOGIC DISORDERS
  • COMBINING NEUROSTIMULATION WITH OTHER THERAPIES
• 5. Using Non-Invasive Neuromodulation for Diagnosis and Research
  • DIAGNOSIS
  • PRESURGICAL MAPPING
  • NEUROMODULATION AS A RESEARCH TOOL
• 6. Enhancement of Brain Function and Performance
  • DIRECT-TO-CONSUMER PRODUCTS
• 7. Ethical, Legal, and Social Issues
  • IMPACT ON “SELF”
  • ENHANCEMENT VERSUS TREATMENT
  • SAFETY AND EFFICACY
  • FREEDOM/COERCION/INVOLUNTARY USE
  • THE DO-IT-YOURSELF MOVEMENT
• 8. Regulatory Issues
  • REGULATORY PATHWAYS
  • ENSURING SAFETY AND EFFICACY
  • CLINICAL TRIAL DESIGN
  • REGULATORY OVERSIGHT FOR OVER-THE-COUNTER USE
• 9. Reimbursement Issues
  • DECISION-MAKING PROCESSES
  • IMPROVING THE EVIDENCE BASE FOR REIMBURSEMENT
  • IMPACT OF NON-REIMBURSEMENT
• 10. The Business Environment
  • INDUSTRY PERSPECTIVES
  • A VENTURE CAPITALIST'S PERSPECTIVE
• APPENDIXES
  • A References
  • B Workshop Agenda
  • C Registered Attendees

Rapporteurs: Lisa Bain, Sheena Posey Norris, and Clare Stroud.

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.

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.