Deep Brain Stimulation for Obsessive-Compulsive Disorder

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen byBenjamin D. Greenberg, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Butler Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study will evaluate the safety and effectiveness of deep brain stimulation in treating people with severe and otherwise treatment-resistant obsessive-compulsive disorder.

Eligibility Criteria

This trial is for adults with severe Obsessive-Compulsive Disorder (OCD) that hasn't improved after trying many treatments, including various medications and therapy. Participants should be in good health overall, have a Yale-Brown OCD Scale score of at least 30, and function poorly in daily life. They can't join if they have psychotic disorders, low IQ, significant cognitive impairments, substance abuse issues, high suicide risk or certain medical conditions.

Inclusion Criteria

Presence of disabling severity, as assessed by a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30

Impaired functioning, indicated by a Global Assessment of Functioning (GAF) score of 45 or less

My illness has been severe and unresponsive to treatment for 5+ years.

+6 more

Exclusion Criteria

Current diagnosis of body dysmorphic disorder

I don't have health issues that would prevent me from having surgery.

Current or unstable remitted substance abuse or dependence

+10 more

Participant Groups

The study tests deep brain stimulation (DBS), where electrodes are implanted to send electrical impulses to specific brain areas. There's an active DBS group getting real treatment and a sham DBS group receiving fake treatment as a comparison. The goal is to see if active DBS safely reduces OCD symptoms better than the sham procedure.

2Treatment groups

Active Control

Placebo Group

Group I: Active DBSActive Control1 Intervention

Participants will receive deep brain stimulation.

Group II: Sham DBSPlacebo Group2 Interventions

Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.