Deep Brain Stimulation for treating severe Obsessive-Compulsive Disorder

Deep Brain Stimulation Surgery for the Treatment of Refractory Obsessive-Compulsive Disorder

This study is testing if Deep Brain Stimulation surgery can help people with severe Obsessive-Compulsive Disorder who haven't found relief from other treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Rabin Medical Center (other)
• Locations: 1 site (Petah Tikva)
• Trial ID: NCT05995951 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of Deep Brain Stimulation (DBS) surgery for patients with refractory Obsessive-Compulsive Disorder (OCD). The study consists of two parts: the first part involves a non-blinded, open trial with two patients, while the second part is a randomized, double-blinded trial with eight patients. All participants will undergo thorough pre-operative assessments and will receive the Medtronic DBS system implantation. The study seeks to determine the safety and efficacy of DBS in reducing OCD symptoms in patients who have not responded to conventional treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with severe OCD symptoms that have persisted for over five years despite multiple treatment attempts.

Not a fit: Patients with severe major depression disorder or significant suicidal risk may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce OCD symptoms and improve the quality of life for patients with refractory OCD.

How similar studies have performed: Previous studies have shown promising results for DBS in treating refractory OCD, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Patients with a diagnosis of obsessive-compulsive disorder according to DSM 5 criteria, diagnosed by three independent psychiatrists not routinely involved with the patients' treatment.
* Severe OCD assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS) with a score of more than 25.
* 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 psychotherapy.
* Meet established criteria for implantation of a deep brain stimulation system.
* Patients between ages 18 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, Bipolar Disorder, Post-Traumatic Stress Disorder (PTSD), Eating Disorder, Autistics Spectrum 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 clinically significant neurological disorder or medical illness affecting brain function, other than a tic disorder.
* Any clinically significant abnormality on preoperative MRI.
* Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors, or other significant medical risk factors for surgery.
* Pregnancy.

Where this trial is running

Petah Tikva

• Rabin Medical Center — Petah Tikva, Israel (RECRUITING)

Study contacts

• Principal investigator: Idit Idit — Rabin Medical Center
• Study coordinator: Idit TamirIdit

Conditions: Obsessive-Compulsive Disorder