CompletedNot Applicable

Focused Ultrasound Amygdala Neuromodulation

United States29 participantsStarted 2022-01-13

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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. * Pregnant women or people trying to become pregnant will also be excluded due to the unknown effects of MRI on developing fetuses * Individu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline on the 30 item Mood and Anxiety Symptom Questionnaire General Distress Subscale score at 6 weeks

Timeframe: Through study completion, around 6 weeks

Change from Baseline fMRI activation to emotional stimuli at 6 weeks

Timeframe: Through study completion, around 6 weeks

Change from Baseline fMRI resting state connectivity at 6 weeks

Timeframe: Through study completion, around 6 weeks

Trial details

NCT IDNCT05228964

SponsorUniversity of Texas at Austin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-01

View on ClinicalTrials.gov More Depression trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from Baseline on the 30 item Mood and Anxiety Symptom Questionnaire General Distress Subscale score at 6 weeks

Timeframe: Through study completion, around 6 weeks

Change from Baseline fMRI activation to emotional stimuli at 6 weeks

Timeframe: Through study completion, around 6 weeks

Change from Baseline fMRI resting state connectivity at 6 weeks

Timeframe: Through study completion, around 6 weeks