Obsessive-Compulsive Disorder (OCD) Clinical Trials

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Towards Closed Loop Deep Brain Stimulation for Treatment of Refractory Obsessive-Compulsive Disorder

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 75
Healthy Volunteers: f
View:

• Patients with a diagnosis of obsessive-compulsive disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria

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

• Refractory OCD; severe symptoms and impairment for more than 5 years despite pharmacological and psychological treatment.

• Have failed to improve following treatment with at least two serotonin transport inhibitors and one augmenting agent taken for an adequate time period.

• Having failed to improve despite adequate cognitive behavioral therapy, as evaluated by the study psychiatrist

• Patients between 22 and 75.

• Ability to understand and sign written informed consent by the patient.

Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Nader Pouratian, M.D., Ph.D.
Nader.Pouratian@UTSouthwestern.edu
2146486630
Backup
Tash Mupambo
Tashinga.Mupambo@UTSouthwestern.edu
214-645-1355
Time Frame
Start Date: 2026-06
Estimated Completion Date: 2031-01
Participants
Target number of participants: 10
Treatments
Experimental: Sham Control stimulation, then Therapeutic stimulation
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.
Experimental: Therapeutic stimulation, then Sham Control stimulation
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.
Experimental: Therapeutic stimulation
All participants will transition to an open label stimulation phase for chronic therapy after the cross-over portion of this trial
Sponsors
Leads: Nader Pouratian

This content was sourced from clinicaltrials.gov