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

NARecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

June 25, 2025

Primary Completion Date

September 16, 2027

Study Completion Date

July 16, 2028

Conditions
Treatment-Resistant DepressionBipolar Depression
Interventions
DEVICE

ExAblate 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.

Trial Locations (1)

Unknown

RECRUITING

Sunnybrook Health Sciences Centre, Toronto

All Listed Sponsors
lead

Sunnybrook Health Sciences Centre

OTHER

NCT07108257 - Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for the Treatment of Refractory Bipolar Depression | Biotech Hunter | Biotech Hunter