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NCT06482762 · ClinicalTrials.gov registry record · Early Phase 1

Low-Intensity Focused Ultrasound of the Amygdala for Bipolar Disorder

A Early Phase 1 study of Bipolar, sponsored by Massachusetts General Hospital.

Recruiting
Registry status
Early Phase 1
Development phase
20
Enrollment target
1
Study location

NCT06482762 is a Early Phase 1 study of Bipolar that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT06482762, a Early Phase 1 study of Bipolar, is actively recruiting participants, sponsored by Massachusetts General Hospital.

RECRUITING
Registry status
Early Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • DEVICE BrainSonix Pulsar 1002

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-07-01
Est. Completion 2025-12-31
Phase Early Phase 1

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT06482762

The ClinicalTrials.gov registry entry for NCT06482762 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Bipolar appearing as the primary indexed condition, and to 1 intervention - of which BrainSonix Pulsar 1002 is the first listed.

NCT06482762 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06482762 about?

NCT06482762 is a clinical study titled "Low-Intensity Focused Ultrasound of the Amygdala for Bipolar Disorder". 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 emotio...

What is the current status of trial NCT06482762?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2024-07-01. Estimated completion is 2025-12-31.

What conditions does trial NCT06482762 study?

This clinical trial studies the following conditions: Bipolar.

What interventions are being tested in trial NCT06482762?

The interventions under investigation include: BrainSonix Pulsar 1002 (DEVICE).

Who is sponsoring clinical trial NCT06482762?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06482762 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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