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ACTIVE NOT RECRUITING

NCT05228964

Focused Ultrasound Amygdala Neuromodulation

Sponsor: University of Texas at Austin

View on ClinicalTrials.gov

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.

Official title: Focused Ultrasound Amygdala Neuromodulation for the Mechanistic Treatment of Affective Disorders

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-01-13

Completion Date

2024-12-31

Last Updated

2024-12-06

Healthy Volunteers

Yes

Conditions

Depression Anxiety Disorders Bipolar Depression Ptsd

Interventions

DEVICE

Focused ultrasound

Focused ultrasound at a 10 Hz pulse repetition frequency, 5% duty cycle, and 720 mw/cm squared de-rated spatial peak temporal average intensity, delivered over 10 min.

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 * 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)

Locations (1)

Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600

Austin, Texas, United States