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NCT05301036 · ClinicalTrials.gov registry record · Phase 1

Personalized Ultrasonic Brain Stimulation for Depression

A Phase 1 study of Major Depressive Episode, sponsored by University of Utah.

Active
Registry status
Phase 1
Development phase
20
Enrollment target
1
Study location

NCT05301036 is a Phase 1 study of Major Depressive Episode that is active but no longer recruiting, run by University of Utah. The registered enrollment target is 20 participants, below the 209-participant average among 7 other Major Depressive Episode trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05301036, a Phase 1 study of Major Depressive Episode, is active but no longer recruiting, sponsored by University of Utah.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
20 participants
Enrollment target
1
Study location

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.

Conditions Studied

Interventions

  • DEVICE Diadem prototype

Study Locations (1)

Utah

  • University of Utah - Salt Lake City

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2022-07-15
Est. Completion 2024-12-14
Phase Phase 1

Sponsor

University of Utah

818 total trials

What the Registry Record Tells You About NCT05301036

The ClinicalTrials.gov registry entry for NCT05301036 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 7 other Major Depressive Episode trials with a reported enrollment target (90% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Major Depressive Episode appearing as the primary indexed condition, and to 1 intervention - of which Diadem prototype is the first listed.

NCT05301036 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.

Frequently Asked Questions

What is clinical trial NCT05301036 about?

NCT05301036 is a clinical study titled "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-tole...

What is the current status of trial NCT05301036?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2022-07-15. Estimated completion is 2024-12-14.

What conditions does trial NCT05301036 study?

This clinical trial studies the following conditions: Major Depressive Episode.

What interventions are being tested in trial NCT05301036?

The interventions under investigation include: Diadem prototype (DEVICE).

Who is sponsoring clinical trial NCT05301036?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05301036 being conducted?

This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.