Deep Brain Stimulation for treating severe Obsessive-Compulsive Disorder

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Rabin Medical Center
  Petah Tikva, Israel Recruiting

Study contacts

• Principal investigator: Idit Idit — Rabin Medical Center
• Study coordinator: Idit TamirIdit
• Email: iditta1@clalit.org.il
• Phone: +972 3 9376406

Similar studies

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

• Low-intensity focused ultrasound targeting the subthalamic nucleus for OCD

  A short test is being done to see if a wearable, non-invasive ultrasound device can safely and tolerably help adults with OCD by targeting a brain region called the subthalamic nucleus.

  Recruiting Phase 2 University of Pennsylvania · Philadelphia, Pennsylvania · NCT07887633

• Mindfulness-Based Cognitive Therapy for OCD Delivered Online

  This study tests a synchronous online MBCT program for adults with OCD to see if it is acceptable and feasible and to explore links between biological markers, OCD severity, and treatment response.

  Recruiting IRCCS Centro San Giovanni di Dio Fatebenefratelli · Brescia · NCT07834567

• Targeted brain stimulation for OCD: test of tTIS on nucleus accumbens

  This study tests whether targeted temporal interference stimulation of the nucleus accumbens can help reduce obsessive-compulsive symptoms in adults with OCD, compared with sham stimulation.

  Recruiting Beijing HuiLongGuan Hospital · Hefei, Anhui · NCT07805200

• Anxiety Skills Study: See if video skill training plus therapy helps people with anxiety

  This study tests whether a brief video-based skill training can help people with anxiety as well as four therapy sessions, and how durable the effects are over a year.

  Recruiting Ohio State University · Columbus, Ohio · NCT07774481

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

  This trial tests ATTN201, a wearable ultrasound headband, to see if it helps adults with OCD compared to a sham treatment.

  Recruiting Phase 2 University of Pennsylvania · San Francisco, California · NCT07728994

• Combined ERP and Habit Reversal Therapy for Tourettic OCD

  This study tests whether a merged Exposure and Response Prevention and Habit Reversal Therapy helps adults with Tourettic OCD more than either therapy alone or basic psychoeducation.

  Recruiting at 2 sites University College London Hospitals · London, London and 1 other locations · NCT07725926

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.