RECRUITING

Low-Intensity Focused Ultrasound of the Amygdala for Bipolar Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Low-Intensity Focused Ultrasound of the Amygdala for Bipolar Disorder

Quick Facts

Study Start:2024-07-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06482762

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Primary diagnosis of BD (can be BD-I or BD-II)
  2. 2. Age 18-64
  3. 3. Normal or corrected-to normal vision and hearing
  4. 4. YMRS ≤ 12
  5. 5. BDI ≥ 14
  1. 1. Active neurological disorder
  2. 2. Current psychosis symptoms
  3. 3. MRI scan contraindications (e.g., metal implant, claustrophobia, weigh over 250 pounds, etc.)
  4. 4. YMRS \> 13
  5. 5. BDI \< 14

Contacts and Locations

Study Contact

Darin Dougherty, MD
CONTACT
617-729-6766
ddougherty@mgb.org
Jason Marum, BA
CONTACT
617-643-2580
jmarum@mgh.harvard.edu

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Ultrasound

Additional Relevant MeSH Terms

  • Bipolar