Recruiting INTERVENTIONAL NCT06902298

Personalized Ultrasonic Brain Stimulation for Depression (R61)

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

Sponsor: Brian Mickey

Conditions Depression - Major Depressive Disorder Major Depressive Episode Treatment-Resistant Major Depressive Disorder

Interventions LTFUS to ALIC LTFUS to SCC

Updated 4 times since 2025 Last updated: Apr 29, 2026 Started: Mar 10, 2025 Primary completion: May 1, 2026 Completion: Nov 1, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Depression - Major Depressive Disorder and Major Depressive Episode and is currently actively recruiting participants. Brian Mickey leads this study, which shows 4 recorded versions since 2025 — indicating limited longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.

Study Description(click to expand)

This R61 project has 3 aims: 1. To determine whether stimulation engages the subcallosal cingulate (SCC) in an intensity-dependent manner 2. To examine the degree of specificity of neuromodulation by contrasting the neural effects of stimulating two spatially distinct targets versus sham 3. To evaluate safety, tolerability, and side effects

This R61 project has 3 aims:

1. To determine whether stimulation engages the subcallosal cingulate (SCC) in an intensity-dependent manner 2. To examine the degree of specificity of neuromodulation by contrasting the neural effects of stimulating two spatially distinct targets versus sham 3. To evaluate safety, tolerability, and side effects

Status Flow

Change History

4 versions recorded

May 4, 2026 — Present [daily]

Recruiting

Phase: PHASE1/PHASE2 → None
Feb 2026 — May 2026 [monthly]

Recruiting PHASE1/PHASE2
Jun 2025 — Feb 2026 [monthly]

Recruiting PHASE1/PHASE2
Apr 2025 — Jun 2025 [monthly]

Recruiting PHASE1/PHASE2

First recorded

Mar 2025

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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.

Contact Information

Sponsor contact:

Brian Mickey
National Institute of Mental Health (NIMH)

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Salt Lake City, United States