Low-Intensity Focused Ultrasound of the Amygdala for Bipolar Disorder

NCT06482762 | Active Not Recruiting Early Phase 1 DMC FDA Device

• 1 other identifier: 2024P001591
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar

Keywords

Ultrasound

Outcome Measures

Primary Outcomes (2)

• Corticolimbic network resting-state functional connectivity

  Changes in amygdala and ventromedial prefrontal cortex resting-state functional connectivity from pre to post amygdala tFUS

  4 weeks

• Mood symptoms

  Changes in Young Mania Rating Scale (YMRS) and Beck's Depression Inventory (BDI)

  4 weeks

Study Arms (1)

Active transcranial focused ultrasound (tFUS)

EXPERIMENTAL

Device: BrainSonix Pulsar 1002

Interventions

BrainSonix Pulsar 1002 DEVICE

Device that delivers low intensity focused ultrasound

Active transcranial focused ultrasound (tFUS)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Neurotherapeutic, Department of Psychiatry

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 1, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)