What this study is
This research project is examining the effects of noninvasive brain stimulation on chronic pain. We believe this study will help us to better understand possible treatments for chronic pain patients. Subjects will undergo functional magnetic resonance imaging (fMRI) and a computed tomography (CT) scan, which is a way to take pictures of the brain and skull. Subjects will receive noninvasive brain stimulation using low-intensity focused ultrasound (LIFU) sound waves, to temporarily change brain activity. Subjects will undergo pain testing using a small device that will increase the temperature of their skin and will rate this pain. Brain signals (EEG), heart rate and rhythm, blood pressure, respiration rate, and skin moisture will be monitored. Subjects will complete behavioral questionnaires. Each study session is expected to take 1.5-3 hours. Total participation takes 10 weeks.
What's being tested
- LIFU
Intervention · DEVICE
Application of low-intensity focused ultrasound for neuromodulation
- Sham LIFU
Intervention · DEVICE
Sham application of LIFU - will appear the same to participants.
Study details
- Official title
- Investigation of Accelerated LIFU: Towards Therapeutic Use for Chronic Pain
- Sponsor
- Virginia Polytechnic Institute and State University
- Conditions
- Chronic Pain
- Enrolling
- 80 people
- Starts
- 2025-01-30
- Est. completion
- 2026-10
- Design
- Double-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients with a chronic pain diagnosis. Pain must be moderate-to-severe and present for at least 3 months prior to research participation. Patients of all ethnicities, who understand and speak English.
You can't join if
- Claustrophobia (scanning environment may be uncomfortable).
- Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
- Contraindications to CT: pregnancy
- Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
- History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
- History of head injury resulting in loss of consciousness for >10 minutes.
- History of alcohol or drug dependence (through self-report).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openFralin Biomedical Research Institute at VTC
Roanoke, Virginia, United States
Study team
Sponsor
Virginia Polytechnic Institute and State University
Study ID 24-994
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.