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Personalized Ultrasonic Brain Stimulation for Depression (R61)

NCT06902298 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

LTFUS to SCC

Low-intensity transcranial focused ultrasound delivered to subgenual cingulate cortex

DEVICE

LTFUS to ALIC

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Brian Mickey

    lead OTHER

Principal Investigators

  • Brian J Mickey · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2026-05-31
Completion
2026-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06902298 on ClinicalTrials.gov