Personalized Ultrasonic Brain Stimulation for Depression (R61)

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Brian Mickey
Study ID
NCT06902298
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • LTFUS to SCC — DEVICE
    Low-intensity transcranial focused ultrasound delivered to subgenual cingulate cortex
  • LTFUS to ALIC — DEVICE
    Low-intensity transcranial focused ultrasound delivered to anterior limb of internal capsule

Study Details

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.

Key Dates

Start date
Mar 10, 2025
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group 1: SCC-ALIC
    Low-intensity transcranial focused ultrasound stimulation (LTFUS) is delivered to the subgenual cingulate cortex (SCC) at the first stimulation visit, then LTFUS is delivered to the anterior limb of the internal capsule (ALIC) at the second stimulation visit.
  • Experimental: Group 2: ALIC-SCC
    Low-intensity transcranial focused ultrasound stimulation (LTFUS) is delivered to the anterior limb of the internal capsule (ALIC) at the first stimulation visit, then LTFUS is delivered to the subgenual cingulate cortex (SCC) at the second stimulation visit.

Primary Outcome Measure

Modulation of SCC activity during SCC stimulation [ Time Frame: Days 14, 21, 28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of UtahSalt Lake CityUtah84108
Brian J Mickey
[email protected]
801-587-0159
Angela Valentina Bisconti
[email protected]
801-587-8972
Brian J Mickey (PRINCIPAL_INVESTIGATOR)

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By research site
University of Utah· Salt Lake City, UT

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