NCT05301036

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

March 20, 2022

Last Update Submit

August 5, 2024

Conditions

Major Depressive Episode

Outcome Measures

Primary Outcomes (4)

  • Target engagement: MRI quantification of brain activation

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

    1 day at MRI study visit

  • Target engagement: MRI quantification of brain connectivity

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

    1 day at MRI study visit

  • Change in depression severity measured with the HDRS-6

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

    1 day and 7 days after stimulation

  • Change in Sadness scale of PANAS-X

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

    1 hour, at stimulation study visit

Study Arms (2)

Active stimulation

EXPERIMENTAL

Personalized low-intensity transcranial focused ultrasound stimulation of deep brain target (subgenual cingulate or alternative targets)

Device: Diadem prototype

Sham stimulation

SHAM COMPARATOR

Personalized low-intensity transcranial focused ultrasound stimulation of lateral ventricle

Device: Diadem prototype

Interventions

Diadem prototypeDEVICE

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

Active stimulationSham stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

  • Riis TS, Feldman DA, Vonesh LC, Brown JR, Solzbacher D, Kubanek J, Mickey BJ. Durable effects of deep brain ultrasonic neuromodulation on major depression: a case report. J Med Case Rep. 2023 Oct 28;17(1):449. doi: 10.1186/s13256-023-04194-4.

    PMID: 37891643DERIVED

Study Officials

  • Brian J Mickey, MD, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

March 20, 2022

First Posted

March 29, 2022

Study Start

July 15, 2022

Primary Completion

July 14, 2024

Study Completion

December 14, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)