Actively Recruiting
Personalized Ultrasonic Brain Stimulation for Depression (R61)
Led by Brian Mickey · Updated on 2026-05-01
30
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
Sponsors
B
Brian Mickey
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Personalized Ultrasonic Brain Stimulation for Depression (R61)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosed with DSM-5 major depressive disorder
- Experiencing a current moderate-to-severe depressive episode lasting at least 2 months without psychotic features
- Self-rated Quick Inventory of Depressive Symptomatology (QIDS) score greater than 10
- History of at least two failed trials of antidepressant medication and/or psychotherapy, with at least one during the current episode
- Willingness to comply with all study procedures and avoid changing psychiatric treatments during the study
- For participants able to become pregnant: negative pregnancy test or use of effective contraception for at least 1 month before baseline and throughout the study
- Ability to provide informed consent and sign consent form
- Currently under care of a licensed mental health provider or addiction specialist and agrees to inform study staff of provider changes
- Agrees to allow communication between study staff and healthcare providers from the past two years for eligibility and safety
- Agrees to provide contact information for at least two people aged 22 or older living within 60 minutes from home for safety contact if needed
You will not qualify if you...
- History of serious brain injury or other neurologic disorder
- Poorly controlled general medical condition
- Pregnant or breastfeeding
- Implanted device in the head or neck
- Unable to tolerate MRI or has MRI contraindications
- Received brain stimulation treatments such as ECT, TMS, or VNS in the past month
- Recent changes in antidepressant treatments within the past month
- Moderate to high risk of suicide according to Columbia-Suicide Severity Rating Scale or clinical judgement
- Suicidal behavior within the past year
- Serious suicide attempt at any time in life
- Moderate-to-severe substance use disorder in past 3 months
- Primary diagnosis of obsessive-compulsive disorder or posttraumatic stress disorder in past month
- Lifetime diagnosis of bipolar-spectrum or schizophrenia-spectrum disorder
- Neurocognitive disorder in past year
- Severe personality disorder
- Deemed clinically inappropriate for participation by the study team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
Research Team
B
Brian J Mickey
CONTACT
S
Sarah Kwon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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