Focused Ultrasound for Severe OCD
This study is testing a new way to treat severe Obsessive-Compulsive Disorder (OCD) using a device called ExAblate MR-guided Focused Ultrasound. This device uses focused sound waves, guided by an MRI, to make a small change in the brain (capsulotomy) that may help reduce OCD symptoms. This approach has already been approved by the FDA for other conditions like Essential Tremor and Parkinson's Disease. The study aims to see if this treatment is safe and effective for people with OCD who haven't found relief from other therapies like psychotherapy and medications. To join, you must be between 25 and 64 years old, have a diagnosis of OCD for at least 5 years, and have severe symptoms (a Y-BOCS score of 28 or higher). The main goal is to see if your OCD symptoms improve after 12 months. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 66 participants. The first stage will involve 10 participants who will act as their own control, receiving standard treatment followed by the ExAblate procedure.
- What's involved
- Participants will receive a best medical treatment protocol for 6 months, followed by the ExAblate MRgFUS procedure plus best medical treatment for another 12 months. You will need to attend study visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after the ExAblate MRgFUS procedure to evaluate symptom changes and any complications.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Sonication-based OCD Neurosurgical Intervention Via Capsulotomy
At a glance
Conditions
Where it's being run
2 sites across 2 statesWho to contact
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What this trial measures
- Phase I: Yale-Brown Obsessive-Compulsive Scale (YBOCS)12 months
Assesses the clinical severity of obsessive-compulsive symptoms (OCD). Higher scores indicate greater severity of OCD symptoms. Primary effectiveness will be evaluated using validated scores; the Y-BOCS score for the OCD patients, based upon patients where bilateral ExAblate capsulotomy was attempted (i.e., intent-to- treat analysis). Efficacy is defined as a reduction of 35% of pre-treatment Y-BOCS score at 12- months post-treatment.
- Phase I: Evaluation of the incidence and severity of procedure related complications12 months
Subjective assessment of safety. The adverse event profile and improvement in Y-BOCS during the 6 months period of BMT will be compared to the adverse event profile and improvement in Y- BOCS during the next 12 months period of ExAblate MRgFUS capsulotomy plus BMT. Success is defined as at least 35% reduction in Y-BOCS in 33% of patients.