Deep brain stimulation for severe, treatment-resistant OCD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• AttunE LIFU for OCD: a non-invasive brain stimulation study

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• Combined ERP and Habit Reversal Therapy for Tourettic OCD

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.