Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder

NCT ID
NCT06660225
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Nader Pouratian
Conditions
Obsessive-Compulsive Disorder

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 10 participants (Estimated).

What is being studied

  • Device: Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation]
  • Device: Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]

Who may be eligible

Ages
22 Years to 75 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Texas, United States: 1

Sample of listed locations

  • University of Texas Southwestern Medical Center — Dallas, Texas, 75390, United States — Recruiting

Study details

Start date
November 1, 2026
Primary completion date
September 1, 2029
Completion date
January 1, 2031
First posted
October 28, 2024

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06660225
Registry last updated
October 1, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT06660225 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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