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NCT05145426 | Enrolling by invitation | Chronic Pain

Investigation of Low-intensity Focused Ultrasound for Human Pain Management
Sponsor:

Virginia Polytechnic Institute and State University

Information provided by (Responsible Party):

Wynn Legon

Brief Summary:

This project examines the effects of noninvasive brain stimulation on pain. The investigators believe this study will help to better understand possible treatments for chronic pain patients. Participants undergo structural imaging, a functional Magnetic Resonance Image (fMRI) and computed tomography (CT). These images are used to align the low-intensity focused ultrasound (LIFU) device which uses sound waves to temporarily change brain activity. Pain testing is done using a small device that will increase/decrease the temperature of the skin. Brain signals are collected using electroencephalography (EEG). Heart rate, blood pressure, and skin moisture will be monitored as well.

Condition or disease

Chronic Pain

Intervention/treatment

Low Intensity Focused Ultrasound

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 80 participants
Masking : None (Open Label)
Masking Description : Sham trials will be utilized within subject. All subjects will receive sham and ultrasound conditions.
Primary Purpose : Basic Science
Official Title : Investigation of Low-intensity Focused Ultrasound for Human Pain Management
Actual Study Start Date : February 4, 2022
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : December 2025
Arm Intervention/treatment

Experimental: Pain Trials

Multi visit - LIFU/Sham application, with quantitative sensory testing (using peltier device).

Device: Low Intensity Focused Ultrasound
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Understand and speak English
Exclusion Criteria
  • MRI/CT/EEG contraindications.
  • Claustrophobia
  • 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
  • History of neurologic disorder
  • History of head injury resulting in loss of consciousness for >10 minutes.
  • History of alcohol or drug dependence
  • Failure to provide Social Security Number or Tax ID number. This is required for tax purposes or payment cannot be processed.
Investigation of Low-intensity Focused Ultrasound for Human Pain Management

Location Details

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Investigation of Low-intensity Focused Ultrasound for Human Pain Management

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Virginia

Fralin Biomedical Research Institute

Roanoke, Virginia, United States, 24016