NCT05228964Completed

Focused Ultrasound Amygdala Neuromodulation

Focused Ultrasound Amygdala Neuromodulation for the Mechanistic Treatment of Affective Disorders

Source: ClinicalTrials.gov · Last updated 29 Apr 2026

Brief summary (registry, in English)

The purpose of the study is to examine the feasibility and potential efficacy of low-intensity focused ultrasound as a method of modulating amygdala function to promote improvements in symptoms of an affective disorder. Ultrasound is frequently and safely utilized for diagnostic purposes. In this study, the investigators will utilize magnetic resonance imaging (MRI) and neuronavigation to target the left amygdala and apply ultrasound. This will be conducted once a day, 5 days a week, for 3 weeks. This will be an open-label, single-arm trial.

Status (registry): Completed
Study type: Interventional
Enrollment: 29 (actual)
First submitted: 13 Jan 2022
Start date: 13 Jan 2022
Primary completion date: 1 Oct 2024
Lead sponsor: University of Texas at Austin
Diseases: Bipolar disorder
NCT number: NCT05228964

What you commit to

Study type: Interventional
Participants enrolled: 29
From 13 Jan 2022 to the primary completion date, 1 Oct 2024
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.

Other illness

Contraindications to LIFUP or MRI including, but not limited to, history of stroke, brain tumors, brain hemorrhages, internal wires, electrodes, pacemakers, implants, irremovable ferromagnetic objects in head that are unsafe for MRI and/or cause large distortions in imaging data, history of seizures (except febrile seizures in childhood), brain surgery, moderate-to-severe head injury or any penetrating head injury, and uncontrolled thyroid disorder.
Individuals with serious medical illnesses that are likely to interfere with study: cancer, autism, narcolepsy etc.
Current substance-use disorder
Individuals currently actively engaged in evidence-based or experimental treatments (e.g., weekly cognitive behavioral psychotherapies, transcranial magnetic stimulation, ketamine/esketamine treatment) other than psychiatric medication(s)

Other

Pregnant women or people trying to become pregnant will also be excluded due to the unknown effects of MRI on developing fetuses
Current active suicidal/homicidal ideation (or suicide attempt in the past 3 months)
Current or recent (within 3 months) psychotic symptoms, or currently meeting diagnostic criteria for a manic episode

Who the study is looking for

Adults ages 18-65
Willing and able to undergo the MRI and LIFUP procedures and repeated LIFUP for up to 15 sessions
English language proficiency sufficient to speak to investigators and understand investigator instruction
Can visit the laboratory several times over the course of 2 to 6 weeks
Individuals with a primary affective disorder diagnosis (major depression, bipolar disorder, an anxiety disorder, or posttraumatic stress disorder on the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders Diagnosis 5th Edition
Score of 19 or greater on the general distress subscale of the 30-item Mood and Anxiety Symptom Questionnaire
Psychiatric medication(s) on a stable dosage and regimen for the past 3 months (including antidepressants, mood stabilizers, atypical antipsychotics, and sedatives/hypnotics)

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600 Coordinator of this site? Confirm its status	Austin	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.