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RECRUITINGEarly Phase 1INTERVENTIONAL

Low-Intensity Focused Ultrasound of the Amygdala for Bipolar Disorder

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

BrainSonix Pulsar 1002

Device that delivers low intensity focused ultrasound

Locations (1)

Massachusetts General Hospital
Boston, Massachusetts, United States