Penn researchers propose guidelines to better protect patients in DBS clinical trials
Promising, early studies of deep brain stimulation (DBS) for the treatment of Alzheimer’s disease have paved a path for future clinical trials, but there are unique ethical challenges with this vulnerable population regarding decision making and post-study treatment access that need to be addressed as they ramp up, Penn Medicine researchers argue. Does the patient still have the capacity to make an informed decision half way through the trial? Are there any misconceptions about its therapeutic benefit? Will the device remain after the trial ends, and who will pay for it? These are the questions posed in an ethics review piece that also lays out guidelines for investigators to consider when enrolling Alzheimer’s patients in DBS trials. The article is authored Andrew M. Siegel, MD, an assistant professor of Clinical Psychiatry in the Perelman School of Medicine at the University of Pennsylvania, Marna S. Barrett, PhD, an adjunct associate professor of Psychology in Psychiatry at Penn and Mahendra T. Bhati, MD, a former assistant professor of Clinical Psychiatry at Penn, who is now at Stanford University, in an ethics review piece that also lays out guidelines for investigators to consider when enrolling Alzheimer’s patients in DBS trials.
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