LIFU for Chronic Pain
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, if you have an active medical disorder or treatment that affects the central nervous system, you may be excluded from participating.
What data supports the effectiveness of the treatment LIFU for chronic pain?
How does LIFU treatment for chronic pain differ from other treatments?
LIFU (Low-Intensity Focused Ultrasound) is unique because it uses sound waves to target and relieve chronic pain, unlike traditional treatments like acupuncture or electroacupuncture, which involve needles and electrical stimulation. This non-invasive approach may offer a novel mechanism for pain relief without the need for medication or physical insertion into the body.16789
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for individuals who have been experiencing moderate-to-severe chronic pain for at least three months. Participants must understand and speak English, but people of all ethnicities are welcome.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Imaging
Participants undergo MRI and CT scans, complete questionnaires, and undergo QST testing
Intervention
Participants receive sham or verum LIFU application with quantitative sensory testing and physiological data collection
Follow-Up Imaging
Participants receive resting-state MRI scans following intervention sessions
Follow-Up Virtual Questionnaires
Participants complete virtual questionnaires to rate pain and report lifestyle impacts
Second Intervention and Follow-Up
Participants undergo a second intervention visit after a minimum 4-week washout period, followed by a 3-week follow-up period
Treatment Details
Interventions
- LIFU
Find a Clinic Near You
Who Is Running the Clinical Trial?
Virginia Polytechnic Institute and State University
Lead Sponsor
Focused Ultrasound Foundation
Collaborator