10
Participants
Start Date
May 24, 2024
Primary Completion Date
May 31, 2028
Study Completion Date
May 31, 2028
Deep Brain Stimulation
"Subjects will be randomized to either ON-OFF (Stimulation-Sham) or OFF-ON (Sham-Stimulation) arms. Patients in the ON-OFF arm will first be treated for up to 12 weeks with the parameters identified during the DBS optimization phase until the washout period. Patients in the OFF-ON will have their devices turned off and will not have their device switched on (activated) until the crossover point.~After completion of the first phase of the trial, patients will undergo another washout phase until they are within 20% of their pre-treatment Y-BOCS II score or 4 weeks have passed, whichever comes first. The purpose of the washout is to eliminate any residual effect of stimulation in the ON group.~Patients will then be advanced to the crossover phase. The participants who were initially randomized to the ON-OFF arm will be moved onto the sham (OFF) period, and the participants who were initially randomized to the OFF-ON group will be moved onto stimulation (ON) period for up to 12 weeks."
RECRUITING
University of California, San Francisco, San Francisco
Andrew Moses Lee, MD, PhD
OTHER