Investigation of Low-intensity Focused Ultrasound for Human Pain Management

May 22, 2026 updated by: Wynn Legon, Virginia Polytechnic Institute and State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

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

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Understand and speak English

Exclusion Criteria:

  • MRI/CT/EEG contraindications.

    1. Claustrophobia
    2. Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
    3. Contraindications to CT: pregnancy
    4. Active medical disorder or treatment with potential CNS effects
    5. History of neurologic disorder
    6. History of head injury resulting in loss of consciousness for >10 minutes.
    7. History of alcohol or drug dependence
    8. Failure to provide Social Security Number or Tax ID number. This is required for tax purposes or payment cannot be processed.

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pain Trials
Multi visit - LIFU/Sham application, with quantitative sensory testing (using peltier device).
Device: Low Intensity Focused Ultrasound
Application of LIFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived sensation score
Time Frame: Assessed per participant, over the course of participation - an average of 3 weeks.
Changed perceived sensation score on a 1-10 scale in response to painful stimuli.
Assessed per participant, over the course of participation - an average of 3 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Windup Pain
Time Frame: Assessed per participant, over the course of participation - an average of 3 weeks
Changed windup pain score on a 1-10 scale.
Assessed per participant, over the course of participation - an average of 3 weeks
CHEP Amplitude
Time Frame: Assessed per participant, over the course of participation - an average of 3 weeks
Attenuated N1/P1 CHEP amplitude recorded with EEG
Assessed per participant, over the course of participation - an average of 3 weeks

Collaborators and Investigators

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

Sponsor

Virginia Polytechnic Institute and State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 4, 2022

Primary Completion (Actual)

July 23, 2025

Study Completion (Actual)

July 23, 2025

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-796

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.

Subscribe