Low-Intensity Focused Ultrasound of the Amygdala for Bipolar Disorder

Description

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.

Conditions

Bipolar

Study Overview

Study Details

Study overview

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.

Low-Intensity Focused Ultrasound of the Amygdala for Bipolar Disorder

Low-Intensity Focused Ultrasound of the Amygdala for Bipolar Disorder

Condition
Bipolar
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Study Record Dates

2025-12-31