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RECRUITING
NCT06482762
EARLY_PHASE1

Low-Intensity Focused Ultrasound of the Amygdala for Bipolar Disorder

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-07-01

Completion Date

2025-12-31

Last Updated

2025-01-07

Healthy Volunteers

No

Conditions

Interventions

DEVICE

BrainSonix Pulsar 1002

Device that delivers low intensity focused ultrasound

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States