A Double-Blinded, Randomized, Crossover Trial of Stereoencephalography- Guided Four-Lead Personalized Deep Brain Stimulation for Treatment-Refractory Obsessive Compulsive Disorder (SEEG-Guided DBS for OCD)
Andrew Moses Lee, MD, PhD
Summary
This is a double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of 4-lead DBS surgery with bilateral IPGs and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment.
Description
The study consists of 3 stages. In Stage 1, the investigators will implant SEEG depth electrodes into various components of the CSTC OCD circuit such as the OFC, ACC, VC/VS, BNST, and amSTN. The investigators will perform extensive stimulation mapping to identify anatomical sites and stimulation parameters that improve symptoms. The investigators also intend to record abnormal local field potential (LFP) activity during periods of varying intensities of spontaneous and provoked OCD symptom severity and will determine if therapeutic stimulation can normalize abnormal neural activity associated…
Eligibility
- Age range
- 22–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. ≥ 22 years and ≤ 75 years of age, at the time of screening 2. Chronic (\> 5 years preceding the date of enrollment) OCD, diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5) 1. Presence of obsessions, compulsions, or both 2. Time-consuming obsessions and compulsions that take more than one hour a day or cause clinically significant distress or impairment in social, occupational, or other important areas of functioning 3. Obsessive-compulsive symptoms that are not attributable to the physiological effects…
Interventions
- DeviceDeep 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.
Location
- University of California, San FranciscoSan Francisco, California