Plain-English translation of NCT07108257 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing a procedure called magnetic resonance-guided focused ultrasound (MRgFUS) capsulotomy as a treatment for bipolar depression that hasn't responded to medication. The procedure uses ultrasound waves guided by MRI scans to create a small lesion in a specific part of the brain thought to be involved in depression. Researchers want to see if this treatment is safe and whether it can help reduce depression symptoms in people who have tried multiple medications without success.
Many people with bipolar depression continue to struggle with severe symptoms even after trying several different medications. This trial exists to explore whether this new brain procedure could offer hope for those whose depression has been resistant to standard treatment options.
You likely qualify if…
You likely don't qualify if…
If you join this trial, you will first go through a 2-month screening period where doctors will confirm you qualify and gather baseline information about your symptoms. Then you will receive the focused ultrasound procedure, which involves lying still in an MRI machine while ultrasound waves are directed at a specific area of your brain. After the procedure, you will have follow-up visits over 24 months where doctors will check how you're doing, assess your depression symptoms using rating scales, ask about any side effects, and evaluate your overall quality of life.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
Canada
Sponsor
Sunnybrook Health Sciences Centre
Enrollment target
~10 participants
Started
June 2025
Primary completion
September 2027
Age range
18 Years – 65 Years
Last updated on clinicaltrials.gov in August 2025.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Nir Lipsman, MD, PhD, FRCSC
Sunnybrook Health Sciences Centre
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.