LIFU for Chronic Pain

Part of paid clinical trials in Roanoke, Virginia.

Sponsor
Virginia Polytechnic Institute and State University
Study ID
NCT06628180
Status
Enrolling By Invitation

Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • LIFU — DEVICE
    Application of low-intensity focused ultrasound for neuromodulation
  • Sham LIFU — DEVICE
    Sham application of LIFU - will appear the same to participants.

Study Details

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.

Key Dates

Start date
Jan 30, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Sham LIFU
    Sham application of LIFU - all follow up (MRI, questionnaires) will be identical.
  • Experimental: Verum LIFU
    Active LIFU application with 3 week follow-up (MRI, questionnaires)

Primary Outcome Measure

Pain sensation [ Time Frame: during 2 study visits - up to 8 times per visit. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fralin Biomedical Research Institute at VTCRoanokeVirginia24016-

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Fralin Biomedical Research Institute at VTC· Roanoke, VA

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