Personalized Ultrasonic Brain Stimulation for Depression (R61)

Launched by BRIAN MICKEY · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new, non-invasive treatment for individuals experiencing depression, specifically targeting those with major depressive disorder who have not found relief from traditional medications or therapy. The treatment involves using low-intensity focused ultrasound to stimulate specific areas of the brain. This method is personalized for each participant based on brain imaging techniques, ensuring the stimulation is aimed precisely at the right spots to help alleviate depressive symptoms.

To be eligible for the trial, participants must be between 18 and 65 years old and have a confirmed diagnosis of major depressive disorder, experiencing a moderate to severe episode for at least two months. They should have tried at least two different antidepressant medications or therapy without success. Participants will be closely monitored throughout the study and are required to maintain their current psychiatric treatments during this time. This trial is currently recruiting and aims to explore the effectiveness of this innovative approach to help those struggling with depression.

Gender

ALL

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.