NCT06902298 Personalized Ultrasonic Brain Stimulation for Depression (R61)
| NCT ID | NCT06902298 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Brian Mickey |
| Condition | Major Depressive Episode |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-03-10 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: 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.
Contact & Investigator
Brian J Mickey
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT06902298 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Episode. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06902298 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06902298 currently recruiting?
Yes, NCT06902298 is actively recruiting participants. Contact the research team at brian.mickey@utah.deu for enrollment information.
Where is the NCT06902298 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT06902298 clinical trial?
NCT06902298 is sponsored by Brian Mickey. The principal investigator is Brian J Mickey at University of Utah. The trial plans to enroll 30 participants.