Study of Low-intensity Focused Ultrasound Effects on Heat Evoked fMRI Signals

August 29, 2023 updated by: Wynn Legon, Virginia Polytechnic Institute and State University
Study aims to examine the effects of noninvasive brain stimulation on brain signals. This insight may have potential clinical implications for addiction, pain, and mental health populations. Participants will receive MRI and CT imaging. Participants receive low-intensity focused ultrasound (LIFU) to temporarily change brain activity. Participants then receive fMRI scans to measure changes in both resting and heat evoked brain signaling using a quantitative sensory testing device. Heart rate, blood pressure, respiratory rate, and skin moisture is monitored. Participants complete a battery of questionnaires, both behavioral and symptom monitoring. The study takes place over 4 study visits.

Study Overview

Status

Recruiting

Conditions

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 Contact

Study Locations

    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Recruiting
        • Fralin Biomedical Research Institute
        • Contact:

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:

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIFU, heat evoked fMRI signals
fMRI resting and heat evoked signals performed after LIFU application to known brain region of interest or active sham region (within participant all conditions tested).
Application of LIFU to induce temporary neuromodulation, effects tested with resting state and heat evoked (QST) fMRI signals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fMRI BOLD Signals
Time Frame: Participant study duration, approximately 3 weeks.
Changes in fMRI BOLD signal
Participant study duration, approximately 3 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in self-reported perceived pain
Time Frame: Participant study duration, approximately 3 weeks.
Change in subject perceived pain rating report on a numerical rating scale (0-10, 0 no pain, 10 worst pain)
Participant study duration, approximately 3 weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monitoring changes to physiological measures
Time Frame: Participant study duration, approximately 3 weeks.
Monitoring for any changes to heartrate, blood pressure, respiratory rate, or galvanic skin response.
Participant study duration, approximately 3 weeks.

Collaborators and Investigators

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

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)

May 6, 2022

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 22-247

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

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.

Clinical Trials on Pain

Clinical Trials on Neuromodulation with low-intensity focused ultrasound

3
Subscribe