NCT06902298

Personalized Ultrasonic Brain Stimulation for Depression (R61)

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Brian Mickey · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-03-10
• Primary completion: 2026-05-01
• Completion: 2026-11-01
• First posted: 2025-03-30
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study