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

Workshop

March 2 - 3, 2015

Past

Materials

About

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)

Contact

Contact us

(202) 334-3265
neuroforum@nas.edu

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Log In

Sign in to access your saved publications, downloads, and email preferences.

Former MyNAP users: You'll need to reset your password on your first login to MyAcademies. Click "Forgot password" below to receive a reset link via email. Having trouble? Visit our FAQ page to contact support.

Members of the National Academy of Sciences, National Academy of Engineering, or National Academy of Medicine should log in through their respective Academy portals.

Email (required)
Password (required)

Don't have an account?

Register

Email (required)
New password (required)
Retype password (required) Password must be at least 8 characters
I accept the terms of use
terms of use

Thank You

Thank you for creating a MyAcademies account!

Enjoy free access to thousands of National Academies' publications, a 10% discount off every purchase, and build your personal library.

Forgot Password

Enter the email address for your MyAcademies (formerly MyNAP) account to receive password reset instructions.

Reset Requested

We sent password reset instructions to your email . Follow the link in that email to create a new password. Didn't receive it? Check your spam folder or contact us for assistance.

Reset Password

New password (required)
Retype password (required) Password must be at least 8 characters

Reset Password

Your password has been reset.

Log In

Verify email

Verify Your Email Address

We sent a verification link to your email. Please check your inbox (and spam folder) and follow the link to verify your email address. If you did not receive the email, you can request a new verification link below

Subscribe

First Name
Last Name
Email (required)
I agree to receive emails from the National Academies (required)

We respect your privacy and will never share your information.

My Academies

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

Dropdown items

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