Actively Recruiting

Phase Not Applicable
Age: 22Years - 75Years
All Genders
NCT06660225

Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder

Led by Nader Pouratian · Updated on 2026-05-05

10

Participants Needed

1

Research Sites

239 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder

Who Can Participate

Age: 22Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of obsessive-compulsive disorder (OCD) according to DSM-5 criteria
  • Severe OCD with Yale-Brown Obsessive-Compulsive Scale (YBOCS) score over 27
  • Refractory OCD with severe symptoms and impairment for more than 5 years despite pharmacological and psychological treatments
  • Failure to improve after treatment with at least two serotonin transport inhibitors and one augmenting agent for adequate periods
  • Failure to improve despite adequate cognitive behavioral therapy as evaluated by study psychiatrist
  • Age between 22 and 75 years
  • Ability to understand and sign written informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of severe major depressive disorder with psychotic features
  • Significant suicidal risk (Hamilton Depression scale item 3 >2)
  • Comorbidity with primary psychotic disorder, post-traumatic stress disorder, or eating disorder
  • History of substance or alcohol dependence or abuse in the past 12 months
  • Significant cognitive decline (MMSE <26 and MoCA <24)
  • Other clinically significant neurological or medical illness affecting brain function (except tic disorder)
  • Clinically significant abnormality on preoperative MRI affecting surgical safety
  • Any contraindications to DBS, infections, coagulopathy, significant cardiac or other surgical risk factors
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

Loading map...

Research Team

N

Nader Pouratian, M.D., Ph.D.

CONTACT

T

Tash Mupambo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here