Investigation of Low-intensity Focused Ultrasound for Human Pain Management

Sponsor
Virginia Polytechnic Institute and State University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05145426
Collaborator
(none)
80
1
1
22.9
3.5

Study Details

Study Description

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 Intervention/Treatment Phase
  • Device: Low Intensity Focused Ultrasound
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Multiple subject repeated measuresMultiple subject repeated measures
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 :
Feb 4, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Perceived sensation score [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.

Secondary Outcome Measures

  1. Windup Pain [Assessed per participant, over the course of participation - an average of 3 weeks]

    Changed windup pain score on a 1-10 scale.

  2. CHEP Amplitude [Assessed per participant, over the course of participation - an average of 3 weeks]

    Attenuated N1/P1 CHEP amplitude recorded with EEG

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fralin Biomedical Research Institute Roanoke Virginia United States 24016

Sponsors and Collaborators

  • Virginia Polytechnic Institute and State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wynn Legon, Assistant Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier:
NCT05145426
Other Study ID Numbers:
  • 21-796
First Posted:
Dec 6, 2021
Last Update Posted:
Mar 21, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wynn Legon, Assistant Professor, Virginia Polytechnic Institute and State University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2022