An ad hoc committee will plan and conduct a two-day public workshop to explore opportunities, challenges, and ethical questions surrounding therapeutic and non-therapeutic uses of non-invasive neuromodulation of the central nervous system.

Presentations and discussions will be designed to:

• 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 such as children

• 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)

The committee will develop the agenda for the workshop, select and invite speakers and discussants, and moderate the discussions. An individually authored workshop summary will be prepared by a designated rapporteur based on presentations and discussions held during the workshop in accordance with institutional guidelines.