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NCT06135064 · ClinicalTrials.gov registry record · Phase 1
Ultrasonic Neuromodulation for Treatment of PTSD
A Phase 1 study, sponsored by University of Utah.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT06135064: Clinical Trial Phase 1 study, sponsored by University of Utah.
NCT06135064 is a Phase 1 study that was terminated before completion, run by University of Utah. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06135064, a Phase 1 study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study will evaluate a new form of non-invasive deep brain therapy for individuals with post-traumatic stress disorder (PTSD). 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 numerical scales of PTSD, cognitive performance, and mood.
Primary Outcome
20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The total severity scores range from 0 to 80.
Interventions
- DEVICE Diadem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-04-05 |
| Est. Completion | 2024-09-27 |
| Phase | Phase 1 |
Why NCT06135064 stopped before completion
NCT06135064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Diadem is the first listed.
NCT06135064 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06135064 about?
NCT06135064 is a clinical study titled "Ultrasonic Neuromodulation for Treatment of PTSD". This study will evaluate a new form of non-invasive deep brain therapy for individuals with post-traumatic stress disorder (PTSD). Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitor...
What is the current status of trial NCT06135064?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2024-04-05. Estimated completion is 2024-09-27.
What interventions are being tested in trial NCT06135064?
The interventions under investigation include: Diadem (DEVICE).
Who is sponsoring clinical trial NCT06135064?
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 NCT06135064's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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