IOM Report on Noninvasive Neuromodulation: State of the Art

Pauline Anderson

July 29, 2015

Noninvasive neuromodulation is gaining ground as a potential treatment for various neurologic disorders. In the coming years, related devices will likely be of increasing interest to clinicians, patients, health systems, payers, and industry, and it's expected that both therapeutic and nontherapeutic applications of these devices will continue to expand.

Given this growing interest, the Institute of Medicine's (IOM's) Forum on Neuroscience and Nervous System Disorders recently convened a workshop, inviting a range of stakeholders including developers of devices, researchers, clinicians, ethicists, regulators, and payers.

The IOM summarized the workshop findings in a report published online July 27.

During the 2-day event, stakeholders explored the issues surrounding the development, regulation, and reimbursement of noninvasive neuromodulation devices for the treatment of nervous system disorders as well as for nontherapeutic uses, including cognitive and functional enhancement.

Currently, three noninvasive neuromodulatory devices are cleared for the treatment of depression and several others have been approved to treat migraine. Additional devices and conditions are being explored. There's promise, for example, in the field of post-stroke treatment of hemiparesis, aphasia, visuospatial neglect, pain, attention disorders, and movement disorders.

As well, several over-the-counter and do-it-yourself devices are being used, according to experts at the workshop.

During the meeting, delegates heard that the neuromodulation field faces significant business-related challenges, including a lack of clarity about navigating through regulatory and reimbursement environments to bring a device to market.

Some delegates expressed concern that the development of devices may be getting ahead of regulation and scientific insight. Others noted that little is known about the mechanisms by which the devices effect clinical improvement.

Research Opportunities

Workshop attendees also discussed research gaps and challenges and potential opportunities in the field. For example, noninvasive neuromodulation may open the door to personalized treatment by enabling a better understanding of the specific neural substrates underlying the symptoms of disease, then targeting the specific neurobiological circuits involved.

But as one expert pointed out, the devices could disrupt regulatory approval of medical devices by further blurring the distinction between medical and nonmedical approaches. They could also interfere with clinical trials by making it more difficult to identify treatment-naive patients and to blind patients as to whether they are receiving treatments or placebo.

In the future, it's possible that neuromodulation will be combined with a drug, cognitive therapy, or behavioral therapy, the report notes. Device companies may join with drug companies to produce combined treatments that are more effective than either approach alone.

Delegates also discussed legal, safety, and ethical considerations around the use of noninvasive neuromodulation. Some pointed out that this approach has the potential to cause not only physical but nonphysical harms. As well, the do-it-yourself movement raises questions about the responsibilities of researchers to educate the public.

Some workshop attendees called for more research as well as larger and longer clinical studies with suitable control interventions.

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