Personalized Ultrasonic Brain Stimulation for Depression

  • STATUS
    Recruiting
  • End date
    Jul 14, 2024
  • participants needed
    20
  • sponsor
    University of Utah
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Updated on 7 October 2022
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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.

Details
Condition Major Depressive Episode
Treatment Diadem prototype
Clinical Study IdentifierNCT05301036
SponsorUniversity of Utah
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 18-65, any gender
Primary diagnosis of major depressive disorder or bipolar disorder
Current moderate-to-severe depressive episode, without psychotic features, lasting at least 2 months
Self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS) total score > 10
Stated willingness to comply with all study procedures and avoid changes to psychiatric treatments (medications, psychotherapy) for the duration of the study
For females 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
MRI intolerance or contraindication
Brain stimulation (e.g., ECT, TMS, VNS) in the past month
Suicidal ideation (Columbia Suicide Severity Rating Scale screen item #2, past month)
Lifetime history of a serious suicide attempt
Moderate-to-severe substance use disorder (past 3 months)
Obsessive compulsive disorder (past month)
Posttraumatic stress disorder (past month)
Schizophrenia-spectrum disorder (lifetime)
Neurocognitive disorder (past year)
Personality disorder as a current focus of treatment
Clinically inappropriate for participation in the study as determined by the study team
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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