SEEG-Guided DBS for Severe OCD
This study is testing a new way to treat severe Obsessive-Compulsive Disorder (OCD) using Deep Brain Stimulation (DBS). DBS involves implanting a device that sends electrical signals to specific brain areas. Before DBS, a procedure called Stereoencephalography (SEEG) will be used to map your brain and find the best areas for stimulation. This study aims to see if this approach can improve OCD symptoms. You might be able to join if you are 22-75 years old and have had chronic OCD for over five years that hasn't responded to other treatments. The study plans to enroll 12 participants. We will measure if this method is feasible, if it can acutely improve OCD symptoms, and if participants are willing to continue with the DBS treatment.
- Study design
- This is a multi-site, double-blinded, randomized, crossover study with 12 planned participants. It involves three stages, including brain mapping and DBS surgery, followed by open-label treatment.
- What's involved
- The study involves three stages: SEEG brain mapping, DBS surgery, and then a randomized treatment period followed by open-label treatment for an additional 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 6 months after the open-label stimulation begins.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
SEEG-Guided DBS for OCD
At a glance
Conditions
Where it's being run
2 sites across 2 statesWho to contact
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What this trial measures
- Primary Feasibility Endpoint #1 - OCD Relevant Network14 days
Percentage of patients in which an OCD relevant network can be identified
- Primary Feasibility Endpoint #2 - Stimulation Target That Acutely Improves OCD Symptoms14 days
Percentage of patients in which we can identify a stimulation target that acutely improves OCD symptoms during SEEG Stage 1
- Primary Feasibility Endpoint #3 - Willingness to Continue with DBS Stage 2Day 14
Percentage of patients willing and able to continue with the DBS Stage 2 after completing the SEEG Stage 1
- Primary Feasibility Endpoint #4 - Acute Symptomatic ImprovementApproximately 60 weeks
Percentage of implanted DBS sites associated with both acute symptomatic improvement during the SEEG Stage 1 and therapeutic benefit during the DBS Stage 2.
- Primary Efficacy Endpoint - Treatment ResponseUp to 24 weeks
Treatment response, determined by the difference in Y-BOCS II score between the active stimulation (ON) condition and sham control (OFF) condition
- 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.