By Michelle Jaffee
In a first-in-human clinical trial of four participants, closed-loop deep brain stimulation was shown to be a feasible, safe and beneficial treatment for difficult-to-treat Tourette syndrome that is unresponsive to optimal conventional medication treatment, University of Florida neuroscientists report today in the journal JAMA Neurology.
Closed-loop deep brain stimulation (DBS) differs from traditional open-loop DBS in that it uses an implanted sensor to record a signal linked to symptoms so that the system automatically adjusts stimulation parameters in real time.
The clinical-research team, co-led by Aysegul Gunduz, Ph.D., an associate professor in the J. Crayton Pruitt Family Department of Biomedical Engineering; Michael Okun, M.D., chair of neurology and executive director of the Norman Fixel Institute for Neurological Diseases at UF Health; and Kelly Foote, M.D., a professor of neurosurgery and co-director of the Norman Fixel Institute, reported that the closed-loop approach had comparable outcomes to conventional continuous open-loop DBS approaches.
DBS is not approved by the U.S. Food and Drug Administration to treat Tourette syndrome, a childhood-onset neurodevelopmental disorder characterized by involuntary motor and vocal tics.
In the new study, funded by the National Institutes of Health, four participants with Tourette syndrome — two male and two female, all over age 21 — received individualized, bilateral closed-loop DBS systems with features customized based on signal quality and tolerance to side effects.
“This study is significant because closed-loop DBS is expected to bring about improved treatment by providing responsive therapeutic stimulation only when necessary, minimizing undesirable side effects and prolonging battery life while effectively suppressing tics,” said Gunduz, the Fixel Brain Mapping Professor at the Norman Fixel Institute.
The most common adverse effects in the study were headaches and anxiety. One limitation of the trial was its small size. Future trials should include a controlled comparison group using cycling or scheduled stimulation, the authors said.