Trials / Terminated
TerminatedNCT06135064
Ultrasonic Neuromodulation for Treatment of PTSD
Deep Brain Therapy With Low-intensity Ultrasound for Treatment of Post-traumatic Stress Disorder
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- University of Utah · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Diadem | The device delivers low-intensity ultrasonic waves into specified brain targets. |
Timeline
- Start date
- 2024-04-05
- Primary completion
- 2024-09-27
- Completion
- 2024-09-27
- First posted
- 2023-11-18
- Last updated
- 2025-05-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06135064. Inclusion in this directory is not an endorsement.