LIFU for Chronic Pain

March 25, 2026 updated by: Wynn Legon, Virginia Polytechnic Institute and State University

Investigation of Accelerated LIFU: Towards Therapeutic Use for Chronic Pain

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This is a 2-arm, sham-controlled, cross-over design. This study is collected over 5-7 study visits.

Initial Imaging (1): MRI and CT scans, Questionnaires, and QST Testing.

Intervention (2): Sham or verum LIFU application every 10 minutes, totaling in 8 applications. Between LIFU or Sham application quantitative sensory testing (QST) will be performed. Physiological data collection such as EEG, EDA, BP, ECG, and Respiration will be collected throughout the study visit.

Follow-Up Imaging (2-4): Following intervention sessions participants will receive a resting-state MRI. This can occur throughout the 4-weeks following an intervention visit. Participants will be scanned at least once after each intervention session.

Follow-Up Virtual Questionnaires: Following intervention sessions participants will receive a link (or a phone call if preferred) to periodically rate their pain and report on various lifestyle impacts of their chronic pain. Participants will complete these questionnaires at least twice per week in the 2 weeks following an intervention visit. These questionnaires will take less than 30 minutes.

After completing the intervention and minimum 4-week washout period, the participant will return for a second intervention visit and 3 week follow-up period.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Fralin Biomedical Research Institute at VTC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham LIFU
Sham application of LIFU - all follow up (MRI, questionnaires) will be identical.
Device: Sham LIFU
Sham application of LIFU - will appear the same to participants.
Experimental: Verum LIFU
Active LIFU application with 3 week follow-up (MRI, questionnaires)
Device: LIFU
Application of low-intensity focused ultrasound for neuromodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain sensation
Time Frame: during 2 study visits - up to 8 times per visit.
Reduced perceived sensation (pain) score in response to painful stimulus. Pain scale of 0-10, 0 being no pain and 10 being worst pain imaginable.
during 2 study visits - up to 8 times per visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 4 weeks following each intervention, every 2-4 days, 30 min per day.
quality of life questionnaires over a 4 week period following intervention
4 weeks following each intervention, every 2-4 days, 30 min per day.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
rs-fMRI
Time Frame: pre and post intervention, up to 5 scans (1 pre, up to 4 post)
Changes in resting state functional connectivity.
pre and post intervention, up to 5 scans (1 pre, up to 4 post)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Polytechnic Institute and State University

Collaborators

Focused Ultrasound Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

October 2, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-994

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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