Deep Brain Stimulation for Obsessive-Compulsive Disorder

Recruiting in Palo Alto (17 mi)

Overseen ByNader Pouratian

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Nader Pouratian

No Placebo Group

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat refractory obsessive-compulsive disorder (OCD). The main questions it aims to answer are: * Assess the effects of the anteromedial sub-thalamic nucleus (amSTN)stimulation on obsessive/compulsive symptoms. * Map the amSTN using neuronal responses \[single unit and local field potentials (LFP) recordings\] at rest and under high frequency stimulation during surgery. * Record chronic brain activity with the implanted pulse generator and look for neuronal signatures correlated with symptom severity. Researchers will compare active deep brain stimulation to a placebo (sham stimulation) to see if DBS works to treat refractory OCD. Participants will: * Undergo surgery for the implantation of a deep brain stimulation device * Follow-up visits every three weeks with study staff * 6 month follow-up for the next 2-3 years after first year of study participation is complete

Eligibility Criteria

This trial is for individuals with severe Obsessive-Compulsive Disorder (OCD) that hasn't improved with standard treatments. Participants will undergo surgery to implant a deep brain stimulation device and must commit to follow-up visits every three weeks, plus long-term check-ups for 2-3 years after the first year.

Inclusion Criteria

I am between 22 and 75 years old.

Severe OCD assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS) with a score of more than 27

I have been diagnosed with obsessive-compulsive disorder.

+4 more

Exclusion Criteria

Significant suicidal risk (Hamilton Depression scale item 3 (suicide) >2)

History of substance or alcohol dependence or abuse in the preceding 12 months

I have a primary psychotic disorder, PTSD, or an eating disorder.

+6 more

Participant Groups

The study tests if activating certain brain areas with Medtronic Percept Deep Brain Stimulation Therapy improves OCD symptoms compared to sham (fake) stimulation. It also involves mapping brain activity related to symptom severity during and after surgery.

3Treatment groups

Experimental Treatment

Group I: Therapeutic stimulation, then Sham Control stimulationExperimental Treatment2 Interventions

Subjects randomized to this arm are initially "ON" DBS prior to the open label period for 16 weeks and then "OFF" DBS for the next 16 weeks. This is followed by an open-label stimulation period.

Group II: Therapeutic stimulationExperimental Treatment1 Intervention

All participants will transition to an open label stimulation phase for chronic therapy after the cross-over portion of this trial

Group III: Sham Control stimulation, then Therapeutic stimulationExperimental Treatment2 Interventions

Subject randomized to this arm are initially "OFF" DBS (Deep Brain Stimulation) prior to the open label period for 16 weeks and then "ON" DBS for the next 16 weeks. This is then followed by an open-label period of DBS stimulation.

Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Deep Brain Stimulation for: