Ultrasonic Neuromodulation for Treatment of PTSD
Purpose
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.
Condition
- PTSD
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Positive PTSD diagnosis; PCL-5 > 20
Exclusion Criteria
- Inability to complete MRI - Suicidal ideation
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Active stimulation |
Low-intensity transcranial focused ultrasound stimulation of deep brain targets affected by PTSD. |
|
|
Sham Comparator Sham stimulation |
Sham stimulation that applies the device in the same way as verum but only delivers auditory sounds correspoding to the ultrasonic pulses. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Utah
