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Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder
Towards Closed Loop Deep Brain Stimulation for Treatment of Refractory Obsessive-Compulsive Disorder
Who can join
Ages 22 to 75 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Diagnosis of severe major depression disorder (MDD) with psychotic features. * Significant suicidal risk \[Hamilton Depression scale item 3 (suicide)\>2\]. * Comorbidity with any primary Psychotic Disorder, Post-Traumatic Stress Disorder (PTSD), or Eating Disorder. * History of substance or alcohol dependence or abuse in the preceding 12 months. * Significant cognitive decline, measured by Mini-Mental State Examination (MMSE \<26) and Montreal Cognitive Assessment (MoCA; \<24). * Any other current clinical significant neurological disorder or medical illness affecting brain function, other than a tic disorder. * Any clinically significant abnormality on preoperative MRI that would affect the safety of the surgical procedure in the opinion of the study neurosurgeon. * Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors, or other medical risk factors for surgery. * Pregnancy.
About the study
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
What is being tested
- Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation] (device)
- Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation] (device)
Sponsor: Nader Pouratian · Participants: 10 · Started: 2026-06
Contact the study team
- Nader Pouratian, M.D., Ph.D. · Phone: 2146486630
- Tash Mupambo · Phone: 214-645-1355
Official record on ClinicalTrials.gov — NCT06660225
Locations in the U.S.
| Texas | University of Texas Southwestern Medical Center, Dallas |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.