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NCT Number: NCT05301036

Personalized Ultrasonic Brain Stimulation for Depression

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Utah

Salt Lake City, Utah, 84108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diadem prototype

Device

Diadem prototype device delivers personalized low-intensity transcranial focused ultrasound stimulation

Primary outcomes

  1. Target engagement: MRI quantification of brain activation

    Time frame: 1 day at MRI study visit

    Blood oxygenation level dependent (BOLD) or arterial spin labeling (ASL) response to active versus sham stimulation

  2. Target engagement: MRI quantification of brain connectivity

    Time frame: 1 day at MRI study visit

    Resting functional connectivity of target in response to active versus sham stimulation

  3. Change in depression severity measured with the HDRS-6

    Time frame: 1 day and 7 days after stimulation

    6-item Hamilton Depression Rating Scale (HDRS-6), range 0-22, higher score represents greater depression

  4. Change in Sadness scale of PANAS-X

    Time frame: 1 hour, at stimulation study visit

    Positive and Negative Affect Schedule Extended (PANAS-X), range 0-100, higher score represents greater sadness

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Personalized Ultrasonic Brain Stimulation for Depression: A Pilot Study of Target Engagement and Mood Effects

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2022
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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