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Procedure

Focused Ultrasound 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
Age 18-64
Primary diagnosis of BD (can be BD-I or BD-II)
Must not have
Active neurological disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the potential of using transcranial focused ultrasound (tFUS) as a treatment for bipolar disorder. The researchers will examine how tFUS affects the brain's activity and

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
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I am between 18 and 64 years old.
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I have been diagnosed with Bipolar Disorder, either Type I or II.
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My vision and hearing are normal, or corrected to normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active neurological condition.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

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Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,340 Total Patients Enrolled
~13 spots leftby Dec 2025
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