Personalized Ultrasonic Brain Stimulation for Depression (R61)
United States30 participantsStarted 2025-03-10
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Modulation of SCC activity during SCC stimulation
Timeframe: Days 14, 21, 28
2
Modulation of SCC activity during ALIC stimulation
Timeframe: Days 14, 21
3
Study dropout
Timeframe: From enrollment to the end of participation at 7 weeks
✕. Brain stimulation treatment such as ECT, TMS, or VNS (past month).
✕. Recent change in antidepressant treatments (past month).
✕. 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