Actively Recruiting
Phase I Trial of Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for Treatment-Resistant Bipolar Depression
Led by Sunnybrook Health Sciences Centre · Updated on 2025-08-06
10
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and initial effectiveness of MR-guided focused ultrasound (MRgFUS) bilateral capsulotomy for patients with treatment-resistant bipolar depression (TRBD). This is a prospective, single-arm, nonrandomized phase I study involving 10 participants. The study aims to assess symptom changes, adverse events, and quality of life after the procedure targeting the anterior limb of the internal capsule in the brain. Participants will undergo MRgFUS capsulotomy using the ExAblate Neuro 4000 device, which performs noninvasive thermal ablation under real-time MRI guidance. All participants receive the same treatment and will be followed for 24 months after the procedure to monitor clinical outcomes. The study includes a 2-month pre-treatment period and a total participation duration of approximately 26 months. During the study, participants will complete various clinical rating scales to measure depression, anxiety, mania, obsessive-compulsive symptoms, suicidal ideation, and quality of life. These assessments occur before treatment and at multiple follow-up points up to 24 months post-treatment. Safety monitoring is focused on adverse events from the treatment day through the follow-up period. The full study duration is about 3 years, with primary results expected within 2 to 3 years.
CONDITIONS
Brief Title
Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for the Treatment of Refractory Bipolar Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 to 65 years of age, inclusive
- Competent and willing to give consent and able to attend study visits as determined by the study Psychiatrist and surgeon
- Diagnosis of Bipolar Disorder Type 1 or Type 2 according to DSM-5
- Minimum score of 20 on the Hamilton Depression Rating Scale (HAMD) during a major depressive episode lasting at least 2 weeks
- Treatment-resistant bipolar depression defined by failure of at least two monotherapy treatments or one monotherapy and one combination treatment for at least 4 weeks
- Ability to provide informed consent and make medical decisions
You will not qualify if you...
- Unstable cardiac conditions such as unstable angina, recent myocardial infarction within 6 months, congestive heart failure requiring medication (other than diuretics), use of anti-arrhythmic drugs, or severe hypertension (diastolic BP > 100 mmHg on medication)
- Contraindications to MRI including non-MRI compatible implanted devices or size limitations
- Abnormal bleeding or coagulopathy with platelet count less than 100,000 per cubic millimeter or abnormal INR
- Recent cerebrovascular disease or intracranial hemorrhage
- Untreated or uncontrolled sleep apnea
- Use of anticoagulant or antiplatelet therapy within 1 week, or drugs increasing bleeding risk within 1 month of procedure
- Unable or unwilling to tolerate prolonged stationary supine position during treatment
- Participation in another clinical trial within the last 30 days
- Inability to communicate with study staff
- Significant cognitive impairment
- History of psychosis or active psychotic, catatonic, or suicidal state
- Presence of brain tumors detected by MRI
- Currently pregnant or breastfeeding
- Chemical abuse or dependence within the last 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a magnetic resonance-guided focused ultrasound (MRgFUS) bilateral capsulotomy targeting the anterior limb of the internal capsule to treat treatment-resistant bipolar depression.
1 treatment day visit (in-person)
Duration - 24 months
Participants are monitored for safety, symptom changes, and quality of life through clinical assessments and rating scales after treatment.
Visits at 1, 3, 6, 12, 18, and 24 months post-treatment
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Actively Recruiting
Research Team
N
Nir Lipsman, MD, PhD, FRCSC
A
Anusha Baskaran, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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