Deep Brain Stimulation for Refractory 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

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.

Conditions2

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