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 range18 Years – 65 Years

SexALL

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…

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 range18 Years – 65 Years

SexALL

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