Low-Intensity Focused Ultrasound and the Complex Patient
Part of paid clinical trials in Roanoke, Virginia.
- Sponsor
- Virginia Polytechnic Institute and State University
- Study ID
- NCT06297200
- Status
- Recruiting
Conditions
- Anxiety Disorder
- Chronic Pain
- Opioid Use Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Low-Intensity Focused Ultrasound — DEVICEA noninvasive brain stimulation device using low-intensity focused ultrasound (LIFU) - ultrasound will be used to test whether noninvasive brain stimulation can effect pain, craving, and anxiety.
- Low-Intensity Focused Ultrasound - sham — DEVICEA sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.
Study Details
Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.
Key Dates
- Start date
- Dec 4, 2024
- Status verified
- Oct 2025
- Primary completion
- Oct 31, 2026
- Completion
- Oct 31, 2026
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Pain, Craving, and Anxiety measuresMulti visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention.
Primary Outcome Measure
Incidence of Treatment-Emergent Adverse Events via a neurological examination [ Time Frame: Assessed per participant, over the course of participation - an average of 4 weeks ]
Central Contacts
- Jessica Florig, MPH540-526-2261
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fralin Biomedical Research Institute at VTC | Roanoke | Virginia | 24016 | Wynn Legon, PhD (PRINCIPAL_INVESTIGATOR) |
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