RECRUITING

Personalized Ultrasonic Brain Stimulation for Depression (R61)

Conditions

Major Depressive Episode Depression - Major Depressive Disorder Treatment-Resistant Major Depressive Disorder ultrasonic neuromodulation low-intensity focused ultrasound

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-10

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06902298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18-65, any gender. 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.	1. History of serious brain injury or other neurologic disorder. 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.

Inclusion Criteria

Exclusion Criteria

1. Age 18-65, any gender.
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.

1. History of serious brain injury or other neurologic disorder.
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.

Contacts and Locations

Study Contact

Brian J Mickey

CONTACT

801-587-0159

brian.mickey@utah.deu

Angela Valentina Bisconti

CONTACT

801-587-8972

angelavalentina.bisconti@utah.edu

Principal Investigator

Brian J Mickey

PRINCIPAL_INVESTIGATOR

University of Utah

Study Locations (Sites)

University of Utah

Salt Lake City, Utah, 84108

United States

Collaborators and Investigators

Sponsor: Brian Mickey

Brian J Mickey, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-10

Study Completion Date2026-11

Study Record Updates

Study Start Date2025-03-10

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

ultrasonic neuromodulation
low-intensity focused ultrasound

Additional Relevant MeSH Terms

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