Stacking the Deck

One of the key themes emerging from the 2019 IEEE Conference on Neural Engineering, held in San Francisco earlier this month, is the often treacherous path of bringing a new neuromodulation therapy from research lab to regulatory approval [see Conference Report, p7]. One of the keynote speakers at the event, Mark George from the Medical University of South Carolina, offered his advice to entrepreneurs seeking to maximize the probability of a successful clinical trial and market approval.

George is in a good position to know, having spent 30 years as an investigator with a strong track record—he was instrumental in gaining FDA approval of both Cyberonics’ VNS therapy and Neuronetics’ TMS therapy for treatment-resistant depression. He voiced concern that technological advances may be far outstripping our clinical knowledge of where to apply the technology. “The rapid growth of brain stimulation startup companies in some ways resembles the California gold rush,” he mused. George highly recommends that neurotech entrepreneurs know their target and know whom to enroll before commencing a clinical trial.

That message does not seem to be lost on Thomas Schläpfer and colleagues from Freiburg University, who published promising results this month on DBS of the medial forebrain bundle for treating depression. “Given recent experiences from pivotal trials in DBS for MDD, we believe that slow, careful, and adaptive study development is germane,” the authors wrote in the journal Neuropsychopharmacology. “After our exploratory study and a large-scale study, we conducted this gateway trial in order to better inform planning of the latter.”

As we report in our article on page 1 of this issue, there are several new neuromodulation approaches on the horizon for treating a range of psychiatric disorders. Vendors seeking FDA approval and reimbursement for new therapies in this space would be wise to copy that slow, careful approach.

Fortunately, there are new tools and techniques available to investigators to help them advice the pitfalls that faced previous sponsors of neuromodulation trials for psychiatric disorders. A California company called MYnd Analytics was recently awarded a European patent for a QEEG technology that predicts the likelihood of a depressed patient responding to TMS therapy. Another firm, Neuronetrix Solutions, LLC, has entered into a consortium with several healthcare manufacturers with the goal of qualifying ERP brain biomarkers to aid the development of new therapies for treating schizophrenia.

Clinical trial sponsors should take advantage of resources such as these to stack the deck with the most likely responders when it comes time to enroll patients.

James Cavuoto
Editor and Publisher