Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder

ConditionObsessive-Compulsive Disorder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age22-75

SponsorNader Pouratian

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

10 Participants

are divided into 3 treatment groups

Sponsors and collaborators

Nader Pouratian

Lead sponsor

University of Texas Southwestern Medical Center

Sponsor institution

Source ClinicalTrials.gov