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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 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 47 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05674903
The ClinicalTrials.gov registry entry for NCT05674903 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Verum stimulation with Diadem prototype is the first listed.
NCT05674903 reports 0 study locations.
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.
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