Personalized Ultrasonic Brain Stimulation for Depression

Last updated: August 5, 2024
Sponsor: University of Utah
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Depression (Major/severe)

Depression

Treatment

Diadem prototype

Clinical Study ID

NCT05301036
IRB_00148802
  • Ages 18-65
  • All Genders

Study 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 first be delivered using a range of stimulation parameters during psychological and physiological monitoring. A well-tolerated stimulation protocol will then be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial to evaluate brain target engagement using magnetic resonance imaging.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-65, any gender

  2. Primary diagnosis of major depressive disorder or bipolar disorder

  3. Current moderate-to-severe depressive episode, without psychotic features, lastingat least 2 months

  4. Self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS) total score > 10

  5. Stated willingness to comply with all study procedures and avoid changes topsychiatric treatments (medications, psychotherapy) for the duration of the study

  6. For females of reproductive potential: negative pregnancy test or use of highlyeffective contraception for at least 1 month prior to baseline; agreement to usesuch a method throughout the study

  7. Capacity to provide informed consent; provision of a signed and dated consent form

Exclusion

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 (e.g., ECT, TMS, VNS) in the past month

  7. Suicidal ideation (Columbia Suicide Severity Rating Scale screen item #2, pastmonth)

  8. Lifetime history of a serious suicide attempt

  9. Moderate-to-severe substance use disorder (past 3 months)

  10. Obsessive compulsive disorder (past month)

  11. Posttraumatic stress disorder (past month)

  12. Schizophrenia-spectrum disorder (lifetime)

  13. Neurocognitive disorder (past year)

  14. Personality disorder as a current focus of treatment

  15. Clinically inappropriate for participation in the study as determined by the studyteam

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Diadem prototype
Phase: 1/2
Study Start date:
July 15, 2022
Estimated Completion Date:
December 14, 2024

Connect with a study center

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

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