Deep brain stimulation for severe, treatment-resistant OCD
Towards Closed Loop Deep Brain Stimulation for Treatment of Refractory Obsessive-Compulsive Disorder
NA · University of Texas Southwestern Medical Center · NCT06660225
This trial will try deep brain stimulation of the anteromedial subthalamic nucleus to see if it reduces symptoms in adults with severe, treatment-resistant OCD.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06660225 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, cross-over trial enrolling up to 10 participants with refractory OCD who will receive bilateral anteromedial subthalamic nucleus (amSTN) DBS leads and an implanted sensing pulse generator. Participants are randomized to start with either therapeutic stimulation or sham (placebo) stimulation for four months, then cross over to the alternate condition, with rescue therapy available if symptoms recur. Intraoperative single-neuron and local field potential recordings will be obtained during symptom provocation, and the implanted device will record chronic brain activity to identify neuronal signatures linked to symptoms. All participants transition to open-label stimulation and are followed regularly (every ~3 weeks initially) with long-term follow-up over the next 2–3 years.
Who should consider this trial
Good fit: Adults aged 22–75 with DSM-5 OCD, severe symptoms (Y-BOCS > 27), and refractoriness after adequate trials of at least two serotonin reuptake inhibitors, one augmenting agent, and cognitive behavioral therapy.
Not a fit: Patients with primary psychotic disorders, severe major depression with psychotic features, significant suicidal risk, or those without truly treatment-refractory OCD are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could reduce obsessive-compulsive symptoms and improve daily functioning for people with severe, treatment-resistant OCD.
How similar studies have performed: Deep brain stimulation at several brain targets has shown benefit in prior trials for refractory OCD, but targeting the anteromedial STN with chronic sensing-capable devices is less extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Nader Pouratian, M.D., Ph.D. — University of Texas Southwestern Medical Center
- Study coordinator: Nader Pouratian, M.D., Ph.D.
- Email: Nader.Pouratian@UTSouthwestern.edu
- Phone: 2146486630
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obsessive-Compulsive Disorder, Obsessive, Compulsive, Deep Brain Stimulation