Focused Ultrasound Amygdala Neuromodulation

Completed · Not applicable

Conditions studied: Depression, Anxiety Disorders, Bipolar Depression, Ptsd

In brief

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.

Key facts

Study ID

NCT05228964

Run by

University of Texas at Austin

People needed

29

Starts

2022-01-13

Expected to finish

2026-04-27

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• Individuals with serious medical illnesses that are likely to interfere with study: cancer, autism, narcolepsy etc.
• Current active suicidal/homicidal ideation (or suicide attempt in the past 3 months)
• Current substance-use disorder
• Current or recent (within 3 months) psychotic symptoms, or currently meeting diagnostic criteria for a manic episode
• 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)

Where it is running

• Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600 — Austin, Texas, United States

Full record on ClinicalTrials.gov

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