Personalized DBS for OCD Guided by Stereoencephalography Mapping

NARecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

May 24, 2024

Primary Completion Date

May 31, 2028

Study Completion Date

May 31, 2028

Conditions
Obsessive-Compulsive DisorderOCD
Interventions
DEVICE

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."

Trial Locations (1)

94143

RECRUITING

University of California, San Francisco, San Francisco

All Listed Sponsors
lead

Andrew Moses Lee, MD, PhD

OTHER