RecruitingNot ApplicableNCT06660225

Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder

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

Sponsor

Nader Pouratian

Enrollment

10 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Obsessive-Compulsive Disorder

Summary

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

Min Age: 22 YearsMax Age: 75 Years

Inclusion Criteria7

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 Criteria9

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.

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Interventions

DEVICEMedtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation]

Deep brain stimulation is a surgery where bilateral electrodes are precisely inserted to specific brain targets affected by a disease state, and electrical stimulation is applied to achieve symptom relief. DBS is a reversible and adjustable treatment option and is now a preferred alternative to neurosurgical ablation. Sham Stimulation=DBS OFF

DEVICEMedtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]