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RecruitingMajor Depressive EpisodeDepression - Major Depressive DisorderTreatment-Resistant Major Depressive Disorder

Personalized Ultrasonic Brain Stimulation for Depression (R61)

Eligible age

18–65 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Brian Mickey

You may qualify if…

  • ✓ 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

You may not qualify if…

  • ✕ 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

Where it's recruiting

Utah

Salt Lake City

Source: ClinicalTrials.gov · NCT06902298 · last updated 2026-05-01

Personalized Ultrasonic Brain Stimulation for Depression (R61) · TrialPath