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NCT05674903 · ClinicalTrials.gov registry record · Phase 1
Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain
A Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT05674903: Completed Phase 1 study, sponsored by University of Utah.
NCT05674903 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05674903, a Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
This study will evaluate a new form of non-invasive deep brain therapy for individuals with generalized chronic pain. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging and CVAS and PROMIS numerical rating scales of pain.
Primary Outcome
MRI quantification of blood oxygenation level dependent (BOLD) activation.
Interventions
- DEVICE Verum stimulation with Diadem prototype
- DEVICE Sham stimulation with Diadem prototype
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2023-07-10 |
| Est. Completion | 2024-08-28 |
| Phase | Phase 1 |
What the finished NCT05674903 record still lists
NCT05674903 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Verum stimulation with Diadem prototype is the first listed.
NCT05674903 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05674903 about?
NCT05674903 is a clinical study titled "Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain". This study will evaluate a new form of non-invasive deep brain therapy for individuals with generalized chronic pain. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-t...
What is the current status of trial NCT05674903?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2023-07-10. Estimated completion is 2024-08-28.
What interventions are being tested in trial NCT05674903?
The interventions under investigation include: Verum stimulation with Diadem prototype (DEVICE), Sham stimulation with Diadem prototype (DEVICE).
Who is sponsoring clinical trial NCT05674903?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05674903's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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