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Procedure

Active transcranial focused ultrasound (tFUS) for Bipolar Disorder

Phase < 1
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Primary diagnosis of BD (can be BD-I or BD-II)
2. Age 18-64
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Summary

The specific aim of this proposed study is to investigate the feasibility and therapeutic potential of transcranial focused ultrasound (tFUS) as a treatment for bipolar disorder (BD). Specifically, the investigators will study the effects of amygdala tFUS on corticolimbic activation during an emotion regulation task in BD, the effects of amygdala tFUS on corticolimbic resting-state functional connectivity in BD, and explore the relationship between tFUS-associated changes in amygdala activity and mood symptoms. The investigators hypothesize that transcranial focused ultrasound (tFUS) of the amygdala will be associated with decreased amygdala activation and increased ventromedial prefrontal cortex activation during a modified version of the Multi-Source Interference Task (MSIT) paired with affective pictures from the International Affective Picture System (IAPS). The investigators also hypothesize that tFUS of the amygdala will be associated with increased resting-state functional connectivity between the amygdala and ventromedial prefrontal cortex. Finally, the investigators hypothesize that tFUS-associated reductions in amygdala activity could be positively correlated with reductions in depressive symptom scores and global improvement.

Who is the study for?
This trial is for individuals with bipolar disorder. Participants should be able to undergo an emotion regulation task and have their brain activity monitored. Details on specific inclusion or exclusion criteria are not provided, but typically these would involve age, health status, and severity of bipolar disorder.
What is being tested?
The study is testing the use of a device called BrainSonix Pulsar 1002 to apply low-intensity focused ultrasound (tFUS) to the amygdala in the brain. The goal is to see if this can affect emotional regulation and improve mood symptoms in people with bipolar disorder.
What are the potential side effects?
Potential side effects are not detailed here, but tFUS may include discomfort at the site of application, headache, or temporary changes in mood or behavior due to stimulation of brain regions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Corticolimbic network resting-state functional connectivity
Mood symptoms

Trial Design

1Treatment groups
Experimental Treatment
Group I: Active transcranial focused ultrasound (tFUS)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,990 Previous Clinical Trials
13,221,390 Total Patients Enrolled
70 Trials studying Bipolar Disorder
18,250 Patients Enrolled for Bipolar Disorder
~13 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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