RecruitingPhase 1Phase 2NCT06902298

Personalized Ultrasonic Brain Stimulation for Depression (R61)

Personalized Ultrasonic Brain Stimulation for Depression: A Study of Target Engagement and Mood Effects


Sponsor

Brian Mickey

Enrollment

30 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate a new form of non-invasive brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will be delivered using a range of stimulation parameters during psychological and physiological monitoring. Individualized optimal targets will be selected using structural MRI and diffusion tractography. Brain target engagement will be evaluated using functional MRI.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing personalized ultrasound brain stimulation (focused ultrasound) as a treatment for moderate-to-severe depression in people who have not responded well to antidepressant medications or therapy. **You may be eligible if...** - You are between 18 and 65 years old - You have a primary diagnosis of major depressive disorder (moderate to severe) - Your current depressive episode has lasted at least 2 months - You have tried at least 2 antidepressant medications or therapies that did not work - You are willing to avoid changes to your psychiatric treatments during the study **You may NOT be eligible if...** - You have psychosis or bipolar disorder - You are currently pregnant or planning to become pregnant during the study - You have metal implants in your head or a pacemaker - You have a history of seizures - You are actively suicidal Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELTFUS to SCC

Low-intensity transcranial focused ultrasound delivered to subgenual cingulate cortex

DEVICELTFUS to ALIC

Low-intensity transcranial focused ultrasound delivered to anterior limb of internal capsule


Locations(1)

University of Utah

Salt Lake City, Utah, United States

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NCT06902298


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