Personalized Ultrasonic Brain Stimulation for Depression (R61)
NCT ID: NCT06902298
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2025-03-10
2026-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Focused Ultrasound Amygdala Neuromodulation
NCT05228964
Deep Brain Stimulation for Refractory Major Depression
NCT00296920
Investigating Transcranial Ultrasound as a Potential Intervention for Depression
NCT02685488
Low Intensity Focused Ultrasound: a New Paradigm for Depression and Anxiety
NCT05147142
Deep Brain Stimulation for Treatment Resistant Depression
NCT04009928
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
LTFUS to SCC
Low-intensity transcranial focused ultrasound delivered to subgenual cingulate cortex
LTFUS to ALIC
Low-intensity transcranial focused ultrasound delivered to anterior limb of internal capsule
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.
LTFUS to SCC
Low-intensity transcranial focused ultrasound delivered to subgenual cingulate cortex
LTFUS to ALIC
Low-intensity transcranial focused ultrasound delivered to anterior limb of internal capsule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LTFUS to SCC
Low-intensity transcranial focused ultrasound delivered to subgenual cingulate cortex
LTFUS to ALIC
Low-intensity transcranial focused ultrasound delivered to anterior limb of internal capsule
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Primary diagnosis of DMS-5 major depressive disorder (MINI).
3. Current moderate-to-severe depressive episode, without psychotic features, lasting at least 2 months (MINI).
4. Self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS) total score \> 10.
5. History of at least 2 failed trials of evidence-based antidepressant medication and/or psychotherapy (at least one trial during the current depressive episode).
6. Stated willingness to comply with all study procedures and avoid changes to psychiatric treatments (medications, psychotherapy) for the duration of the study.
7. For participants of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study.
8. Capacity to provide informed consent; provision of a signed and dated consent form
9. Currently are under the care of a licensed psychiatrist or other mental health care provider, or a licensed addiction medicine specialist and agrees to promptly inform the investigator or the study staff of any change in these providers.
10. Agrees to allow any and all forms of communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years of study enrollment for the purposes of eligibility confirmation or in case of a safety event.
11. Agrees to provide the name and verifiable contact information (email and mailing addresses, mobile and land-line phone numbers, as applicable) of at least two persons 22 years or older who reside within a 60-minute drive of the patient's residence. Subject agrees that in the event of a safety concern or event during study participation, research staff is at liberty to contact these individuals if the subject does not respond to contact attempts.
Exclusion Criteria
2. Poorly managed general medical condition.
3. Pregnant or breast feeding.
4. Implanted device in the head or neck.
5. MRI intolerance or contraindication.
6. Brain stimulation treatment such as ECT, TMS, or VNS (past month).
7. Recent change in antidepressant treatments (past month).
8. 8\. Moderate-High Risk of Suicide according to the Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (answers YES to Question 3 and NO to Question 6 (Moderate risk) or YES to Question 4, 5, or 6 (High risk)) and/or in the clinical judgement of the PI or a study psychiatrist
9. Suicidal behavior (past year).
10. Serious suicide attempt 33 (lifetime).
11. Moderate-to-severe substance use disorder (MINI, past 3 months).
12. Obsessive compulsive disorder, primary diagnosis (MINI, past month).
13. Posttraumatic stress disorder, primary diagnosis (MINI, past month).
14. Bipolar-spectrum disorder (MINI, lifetime).
15. Schizophrenia-spectrum disorder (MINI, lifetime).
16. Neurocognitive disorder (DSM-5, past year).
17. Severe personality disorder.
18. Clinically inappropriate for participation in the study as determined by the study team.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
Brian Mickey
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Brian Mickey
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brian J Mickey
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Utah
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB_00148802R61
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.