Personalized Ultrasonic Brain Stimulation for Depression (R61)

NCT06902298 | Recruiting Phase 1 DMC FDA Device

• 2 other identifiers: IRB_00148802R61R61MH134943
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

ultrasonic neuromodulation; low-intensity focused ultrasound

Outcome Measures

Primary Outcomes (3)

• Modulation of SCC activity during SCC stimulation

  Functional MRI is used to quantify modulation of SCC activity during SCC stimulation

  Days 14, 21, 28

• Modulation of SCC activity during ALIC stimulation

  Functional MRI is used to quantify modulation of SCC activity during ALIC stimulation

  Days 14, 21

• Study dropout

  Dropout or withdrawal due to stimulation-related adverse effects

  From enrollment to the end of participation at 7 weeks

Secondary Outcomes (9)

• PANAS-X

  Immediately before and after each LTFUS on Days 14, 21, 28

• MADRS

  Days 14, 21, 28, 35, 49

• HDRS-6

  Days 0, 14, 15, 21, 22, 28, 29, 35, 49

• IDS-SR

  Days 0, 14, 21, 28, 35, 49

• GAD-7

  Days 0, 14, 21, 28, 35, 49

Study Arms (2)

Group 1: SCC-ALIC

EXPERIMENTAL

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.

Device: LTFUS to SCC; Device: LTFUS to ALIC

Group 2: ALIC-SCC

EXPERIMENTAL

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.

Device: LTFUS to SCC; Device: LTFUS to ALIC

Interventions

LTFUS to SCC DEVICE

Low-intensity transcranial focused ultrasound delivered to subgenual cingulate cortex

Group 1: SCC-ALIC; Group 2: ALIC-SCC

LTFUS to ALIC DEVICE

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

Group 1: SCC-ALIC; Group 2: ALIC-SCC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65, any gender.
• Primary diagnosis of DMS-5 major depressive disorder (MINI).
• Current moderate-to-severe depressive episode, without psychotic features, lasting at least 2 months (MINI).
• Self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS) total score \> 10.
• History of at least 2 failed trials of evidence-based antidepressant medication and/or psychotherapy (at least one trial during the current depressive episode).
• Stated willingness to comply with all study procedures and avoid changes to psychiatric treatments (medications, psychotherapy) for the duration of the study.
• 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.
• Capacity to provide informed consent; provision of a signed and dated consent form
• 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.
• 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.
• 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.

You may not qualify if:

• History of serious brain injury or other neurologic disorder.
• Poorly managed general medical condition.
• Pregnant or breast feeding.
• Implanted device in the head or neck.
• MRI intolerance or contraindication.
• Brain stimulation treatment such as ECT, TMS, or VNS (past month).
• Recent change in antidepressant treatments (past month).
• \. 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
• Suicidal behavior (past year).
• Serious suicide attempt 33 (lifetime).
• Moderate-to-severe substance use disorder (MINI, past 3 months).
• Obsessive compulsive disorder, primary diagnosis (MINI, past month).
• Posttraumatic stress disorder, primary diagnosis (MINI, past month).
• Bipolar-spectrum disorder (MINI, lifetime).
• Schizophrenia-spectrum disorder (MINI, lifetime).

Sponsors & Collaborators

• Brian Mickey: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

Study Officials

• Brian J Mickey

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian J Mickey

CONTACT

801-587-0159; brian.mickey@utah.deu

Sarah Kwon

CONTACT

801-829-7382; utah.depression.research@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All individuals are masked except the device operator
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Two brain targets will be stimulated sequentially. The order of the two targets will be randomized.

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: March 10, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)