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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: Active Phase 1 study of Major Depressive Episode, sponsored by University of Utah.
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. According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-07-15 |
| Est. Completion | 2024-12-14 |
| Phase | Phase 1 |
What the registry record for NCT05301036 still lists
NCT05301036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 209-participant average among 7 other Major Depressive Episode trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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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