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Investigation of Low-intensity Focused Ultrasound for Human Pain Management

Primary Purpose

Chronic Pain

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Intensity Focused Ultrasound
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Pain focused on measuring Low-intensity focused ultrasound

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fralin Biomedical Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pain Trials

Arm Description

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

Outcomes

Primary Outcome Measures

Perceived sensation score
Changed perceived sensation score on a 1-10 scale in response to painful stimuli.

Secondary Outcome Measures

Windup Pain
Changed windup pain score on a 1-10 scale.
CHEP Amplitude
Attenuated N1/P1 CHEP amplitude recorded with EEG

Full Information

First Posted
November 10, 2021
Last Updated
June 6, 2023
Sponsor
Virginia Polytechnic Institute and State University
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1. Study Identification

Unique Protocol Identification Number
NCT05145426
Brief Title
Investigation of Low-intensity Focused Ultrasound for Human Pain Management
Official Title
Investigation of Low-intensity Focused Ultrasound for Human Pain Management
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 4, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Low-intensity focused ultrasound

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multiple subject repeated measures
Masking
None (Open Label)
Masking Description
Sham trials will be utilized within subject. All subjects will receive sham and ultrasound conditions.
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain Trials
Arm Type
Experimental
Arm Description
Multi visit - LIFU/Sham application, with quantitative sensory testing (using peltier device).
Intervention Type
Device
Intervention Name(s)
Low Intensity Focused Ultrasound
Intervention Description
Application of LIFU
Primary Outcome Measure Information:
Title
Perceived sensation score
Description
Changed perceived sensation score on a 1-10 scale in response to painful stimuli.
Time Frame
Assessed per participant, over the course of participation - an average of 3 weeks.
Secondary Outcome Measure Information:
Title
Windup Pain
Description
Changed windup pain score on a 1-10 scale.
Time Frame
Assessed per participant, over the course of participation - an average of 3 weeks
Title
CHEP Amplitude
Description
Attenuated N1/P1 CHEP amplitude recorded with EEG
Time Frame
Assessed per participant, over the course of participation - an average of 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Fralin Biomedical Research Institute
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24413698
Citation
Legon W, Sato TF, Opitz A, Mueller J, Barbour A, Williams A, Tyler WJ. Transcranial focused ultrasound modulates the activity of primary somatosensory cortex in humans. Nat Neurosci. 2014 Feb;17(2):322-9. doi: 10.1038/nn.3620. Epub 2014 Jan 12.
Results Reference
background
PubMed Identifier
20103504
Citation
Tyler WJ. Noninvasive neuromodulation with ultrasound? A continuum mechanics hypothesis. Neuroscientist. 2011 Feb;17(1):25-36. doi: 10.1177/1073858409348066. Epub 2010 Jan 25.
Results Reference
background
PubMed Identifier
29463641
Citation
Kubanek J, Shukla P, Das A, Baccus SA, Goodman MB. Ultrasound Elicits Behavioral Responses through Mechanical Effects on Neurons and Ion Channels in a Simple Nervous System. J Neurosci. 2018 Mar 21;38(12):3081-3091. doi: 10.1523/JNEUROSCI.1458-17.2018. Epub 2018 Feb 20.
Results Reference
background
PubMed Identifier
27782686
Citation
Kamimura HA, Wang S, Chen H, Wang Q, Aurup C, Acosta C, Carneiro AA, Konofagou EE. Focused ultrasound neuromodulation of cortical and subcortical brain structures using 1.9 MHz. Med Phys. 2016 Oct;43(10):5730. doi: 10.1118/1.4963208.
Results Reference
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Investigation of Low-intensity Focused Ultrasound for Human Pain Management

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