Using focused ultrasound on the amygdala to treat bipolar disorder
Low-Intensity Focused Ultrasound of the Amygdala for Bipolar Disorder
This study is testing if focused ultrasound on a specific part of the brain can help improve mood and emotional control in people with bipolar disorder.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06482762 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and therapeutic potential of transcranial focused ultrasound (tFUS) targeting the amygdala as a treatment for bipolar disorder (BD). The researchers will assess the effects of tFUS on brain activation during emotion regulation tasks and its impact on resting-state functional connectivity in individuals with BD. The study aims to explore the relationship between changes in amygdala activity due to tFUS and mood symptoms in patients. By examining these effects, the study seeks to identify a new, tolerable treatment option for those suffering from BD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-64 with a primary diagnosis of bipolar disorder who meet specific mood symptom criteria.
Not a fit: Patients with active neurological disorders, current psychosis symptoms, or contraindications for MRI scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and tolerable treatment option for patients with bipolar disorder.
How similar studies have performed: While neuromodulation techniques like transcranial magnetic stimulation have shown success in treating mood disorders, the specific use of tFUS for bipolar disorder is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Primary diagnosis of BD (can be BD-I or BD-II) 2. Age 18-64 3. Normal or corrected-to normal vision and hearing 4. YMRS ≤ 12 5. BDI ≥ 14 Exclusion Criteria: 1. Active neurological disorder 2. Current psychosis symptoms 3. MRI scan contraindications (e.g., metal implant, claustrophobia, weigh over 250 pounds, etc.) 4. YMRS \> 13 5. BDI \< 14
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Darin Dougherty, MD
- Email: ddougherty@mgb.org
- Phone: 617-729-6766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.