Low-Intensity Focused Ultrasound of the Amygdala for Bipolar Disorder
Running, not enrolling · Early Phase 1
Conditions studied: Bipolar
In brief
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 facts
- Study ID
- NCT06482762
- Run by
- Massachusetts General Hospital
- People needed
- 20
- Starts
- 2024-07-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-05-07
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Primary diagnosis of BD (can be BD-I or BD-II)
- Age 18-64
- Normal or corrected-to normal vision and hearing
- YMRS ≤ 12
- BDI ≥ 14
You may not qualify if…
- Active neurological disorder
- Current psychosis symptoms
- MRI scan contraindications (e.g., metal implant, claustrophobia, weigh over 250 pounds, etc.)
- YMRS > 13
- BDI < 14
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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