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
Sunnybrook Health Sciences Centre
10 participants
Jun 25, 2025
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
Plain Language Summary
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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
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)
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NCT07108257