Reforming the process for DBS and neurological device approval in rare diseases

Doctor Michael Okun
Dr. Michael Okun

For some patients with common neurological diseases like Parkinson’s disease, treatment using neurotechnological devices such as deep brain stimulation has been successful in improving their symptoms.

But in a new JAMA Neurology Viewpoint article, Michael S. Okun, M.D., UF’s chair of neurology, and James Giordano, Ph.D., of Georgetown University, argue that reform is needed in the current U.S. approval process for these devices to treat rare diseases and rare disease subtypes, such as severe Tourette syndrome.

The authors state that increasing knowledge and identification of rare neurological diseases and the expansion and sophistication of available neurotechnological devices necessitate this reform.

“Patients with rare diseases deserve the benefit of available and affordable access to new and evidence-validated technologies,” wrote Okun, director of the Norman Fixel Institute for Neurological Diseases at UF Health, and Giordano, chief of the neuroethics studies program at Georgetown.

Read the Viewpoint article in JAMA Neurology.