Meeting

Non-Invasive Neuromodulation of the Central Nervous System: A Workshop


When: March 2, 2015 - March 3, 2015 (8:30 AM Eastern)
Where: Keck Center (Room 100) • 500 Fifth St. NW, Washington, DC 20001

Topics Biomedical and Health Research, Substance Use and Mental Health, Diseases, Aging, Public Health, Quality and Patient Safety
Activity: Forum on Neuroscience and Nervous System Disorders
Board: Board on Health Sciences Policy

Based on advances in biotechnology and neuroscience, neuromodulation devices are poised to gain clinical importance in the coming years and to be of increasing interest to patients, health care providers and payers, and industry. Emerging evidence suggests that the potential therapeutic and non-therapeutic uses of non-invasive neuromodulation devices for the central nervous system are broad and will continue to expand. Along with the growing number of opportunities, there are challenges and open questions associated with the use of these devices. Currently, there is a need for greater understanding of the potential benefits and risks; in particular, of the short- and long-term impact of using these devices. From a regulatory standpoint, there are scientific and clinical questions that are important for regulatory approval and usability for consumers. A third area of consideration is the existing, and appropriate, levels of evidence for reimbursement. Several issues raise ethical questions, including the potential for off-label, over-the-counter, or “do it yourself” uses or for enhancement. Given the growing interest in non-invasive neuromodulation devices for the central nervous system, the goal of this workshop was to explore opportunities, challenges, and ethical questions surrounding the development, regulation and reimbursement of such devices.

Workshop Objectives:

  • Highlight potential benefits and risks of non-invasive neuromodulation based on known short and long-term central nervous system mechanisms of action
    • Explore the scientific landscape of non-invasive neuromodulation device development for both therapeutic and non-therapeutic uses
      • Consider issues concerning vulnerable populations
  • Consider the regulatory landscape for non-invasive neuromodulation devices
    • Discuss potential outcome measures for therapeutic uses in regulatory processes
    • Explore pathways for regulatory approval of therapies utilizing a combination of non-invasive neuromodulation devices and pharmaceuticals
    • Discuss differences in regulatory pathways among countries
  • Explore current and potential use reimbursement practices for therapeutic use of non-invasive neuromodulation devices
    • Explore the evidence base and acceptable therapeutic outcome measures utilized in reimbursement decisions
      • Consider economic outcome measures used to determine payer practices
  • Examine ethical questions around the use of non-invasive neuromodulation devices
    • Consider ethical issues of off-label and over-the counter use on regulation, reimbursement and patient safety
      • Discuss the use of these devices for enhancement in individuals without an impaired baseline
      • Consider the implications of involuntary or coercive use (e.g., children, court ordered treatment)

Previous Meetings for this Activity

Also of Interest