Personalized Ultrasonic Brain Stimulation for Depression (R61)
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 b
| Condition(s) | Major Depressive Episode, Depression - Major Depressive Disorder, Treatment-Resistant Major Depressive Disorder |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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 | 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; agreeme |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Brian Mickey |
| Locations | Salt Lake City, Utah, United States |
| Start date | 2025-03-10 |
| NCT ID | NCT06902298 |
| Official listing | https://clinicaltrials.gov/study/NCT06902298 |