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NCT06131502 · ClinicalTrials.gov registry record · Phase 1
Sonication-based OCD Neurosurgical Intervention Via Capsulotomy
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Not yet
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT06131502 is a Phase 1 study that has not yet begun recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 66 participants.
The verdict
NCT06131502, a Phase 1 study, has not yet begun recruiting, sponsored by Brigham and Women's Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to determine if ExAblate MR-guided Focused Ultrasound (MRgFUS) bilateral anterior capsulotomy can be used safely and effectively to relieve symptoms of moderate to severe obsessive compulsive disorder (OCD) in individuals who have not benefited from psychotherapy and medications. The main questions it aims to answer are: 1. Can ExAblate MRgFUS capsulotomy be safely delivered to individuals suffering from treatment-refractory OCD through an intact skull with a risk and side-effect profile that is comparable to other neurosurgical approaches for capsulotomy? 2. Will ExAblate MRgFUS capsulotomy result in improvement in clinical symptoms and quality of life metrics that are similar to those seen with other surgical approaches for capsulotomy? In the first stage of the study, participants with severe, treatment resistant OCD (n=10) will be recruited in two centers (Harvard and Stanford) and treated with best medical care (BMT) for 6 months. Thereafter, they will receive the ExAblate MRgFUS procedure and then another BMT for 12 months. In the second stage of the study, participants with moderate to severe OCD (n=56) will be recruited in a multi-center study and treated with BMT plus real or sham MRgFUS for 12 months. Thereafter, those who received sham MRgFUS and did not improve will receive real MRgFUS and then treated with BMT for another 12 months.
Interventions
- DEVICE ExAblate MR-guided Focused Ultrasound Bilateral Anterior Capsulotomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2026-08 |
| Est. Completion | 2032-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06131502
The ClinicalTrials.gov registry entry for NCT06131502 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ExAblate MR-guided Focused Ultrasound Bilateral Anterior Capsulotomy is the first listed.
NCT06131502 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06131502 about?
NCT06131502 is a clinical study titled "Sonication-based OCD Neurosurgical Intervention Via Capsulotomy". The goal of this clinical trial is to determine if ExAblate MR-guided Focused Ultrasound (MRgFUS) bilateral anterior capsulotomy can be used safely and effectively to relieve symptoms of moderate to severe obsessive compulsive disorder (OCD) in individuals who have not benefited from psychotherapy a...
What is the current status of trial NCT06131502?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2026-08. Estimated completion is 2032-08.
What interventions are being tested in trial NCT06131502?
The interventions under investigation include: ExAblate MR-guided Focused Ultrasound Bilateral Anterior Capsulotomy (DEVICE).
Who is sponsoring clinical trial NCT06131502?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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