RecruitingNot ApplicableNCT07108257

Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for the Treatment of Refractory Bipolar Depression

Phase I Trial of Magnetic Resonance-Guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Bipolar Depression


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

10 participants

Start Date

Jun 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the safety and initial effectiveness of MR-guided focused ultrasound (MRgFUS) bilateral capsulotomy in patients with treatment-resistant bipolar depression (TRBD).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a non-invasive brain treatment called MRI-guided focused ultrasound capsulotomy for people with severe bipolar depression that has not responded to multiple medications. This procedure uses sound waves — guided precisely by MRI — to target specific brain circuits involved in depression, without any surgery or incisions. **You may be eligible if:** - You are between 18 and 65 years old - You have a diagnosis of Bipolar Disorder Type 1 or Type 2 - You are currently in a depressive episode with a significant depression score on a standardized scale - Your bipolar depression has not responded to at least two different medication regimens tried for at least 4 weeks each - You are able to give informed consent and attend study visits **You may NOT be eligible if:** - You do not have treatment-resistant bipolar depression - You have conditions that make focused ultrasound or MRI unsafe - You are under 18 or over 65 - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExAblate Neuro 4000

ExAblate Neuro 4000 is an MR-guided focused ultrasound (MRgFUS) device used to perform noninvasive thermal ablation of targeted brain tissue. In this study, ExAblate Neuro 4000 will be used to ablate the anterior limb of the internal capsule (capsulotomy) in patients with treatment-resistant bipolar depression (TRBD). The procedure is conducted under real-time MRI guidance and thermometry to assess safety and initial effectiveness in improving clinical symptoms and quality of life.


Locations(1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT07108257


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