NCT06482762Active, not recruitingEarly phase 1
Low-Intensity Focused Ultrasound of the Amygdala for Bipolar Disorder
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 26 Jun 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Bipolar disorder
- NCT number
- NCT06482762
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 20
- From 1 Jul 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- MRI scan contraindications (e.g., metal implant, claustrophobia, weigh over 250 pounds, etc.)
Other illness
- Active neurological disorder
Other
- Current psychosis symptoms
- YMRS \> 13
- BDI \< 14
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.