Personalized DBS for OCD Guided by Stereoencephalography Mapping
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- A Moses Lee, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
- Andrew Krystal, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Primary Feasibility Endpoint #1 - Stimulation Target That Acutely Improves OCD Symptoms12 days
Percentage of patients in which the investigators can identify a stimulation target that acutely improves OCD symptoms during the SEEG Stage 1
- Primary Feasibility Endpoint #2 - Identifying an electrophysiological biomarker of OCD12 days
Percentage of patients in which an electrophysiological biomarker of OCD can be identified during the SEEG Stage 1
- Primary Feasibility Endpoint #3 - Acute Symptomatic Improvement18 months
Percentage of implanted DBS sites associated with acute symptomatic improvement during the SEEG Stage 1 that also have long-term therapeutic benefit during the DBS Stage 2
- Primary Feasibility Endpoint #4 - Completion of Stages 1 and 218 months
Percentage of enrolled patients completing SEEG Stage 1 and Stage 2 of the trial
- Primary Safety Endpoint - Serious Adverse EventsApproximately 4 years
Number and type of serious adverse events in this SEEG-guided 4-lead DBS approach compared to conventional DBS for OCD.
- Primary Efficacy Endpoint - Treatment ResponseApproximately 4 years
Treatment response, determined by the difference in Yale-Brown Obsessive Compulsive Scale (YBOCS) II score between the active stimulation (ON) condition and sham control (OFF) condition