Examining the effects of low-intensity focused ultrasound on brain signals related to pain
Study of Low-intensity Focused Ultrasound Effects on Heat Evoked fMRI Signals
This study is testing if a gentle ultrasound treatment can change brain signals related to pain to help people manage their pain better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Virginia Polytechnic Institute and State University Academic / other |
| Locations | 1 site (Roanoke, Virginia) |
| Trial ID | NCT05303415 on ClinicalTrials.gov |
What this trial studies
This study investigates how noninvasive brain stimulation using low-intensity focused ultrasound (LIFU) affects brain activity and signals related to pain. Participants will undergo MRI and CT imaging to assess changes in brain function before and after LIFU treatment. The study includes monitoring of physiological responses such as heart rate and blood pressure, as well as behavioral assessments through questionnaires. The research aims to provide insights that could have clinical implications for managing pain and other related conditions.
Who should consider this trial
Good fit: Ideal candidates are healthy volunteers who are fluent in English and do not have any contraindications for MRI or CT scans.
Not a fit: Patients with a history of neurological disorders, active medical conditions affecting the CNS, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new noninvasive treatments for pain management.
How similar studies have performed: While the approach of using low-intensity focused ultrasound is relatively novel, similar studies in neuromodulation have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy volunteers, all ethnicities, who understand and speak English. Exclusion Criteria: 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).
Where this trial is running
Roanoke, Virginia
- Fralin Biomedical Research Institute — Roanoke, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Jessica W Florig, MPH
- Email: legonlab@vtc.vt.edu
- Phone: 540-526-2261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.