Investigation of the Duration of Low-intensity Focused Ultrasound

February 19, 2024 updated by: Wynn Legon, Virginia Polytechnic Institute and State University
This project examines the effects of various durations of noninvasive neuromodulation on muscle contractions. The investigators believe this study will help to better understand noninvasive brain stimulation techniques that may have the potential to aid in addiction, pain, and mental health issues. 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) and transcranial magnetic stimulation (TMS) devices to temporarily change brain activity. Electromyography (EMG) will be used to record muscle contractions of the hand.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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

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:

  • Above criteria and must understand and speak English.

Exclusion Criteria:

  • Contraindications to MRI, CT, or TMS

    1. Claustrophobia
    2. Pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
    3. 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

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: Duration Trials
Six different durations (three intermittent and three continuous) of LIFU application will be tested across six study sessions. Response recorded using TMS and EMG.
Device: Low-Intensity Focused Ultrasound
LIFU application using various durations, responses of neuromodulation recorded using TMS and EMG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waveforms
Time Frame: Outcomes assessed throughout participation - an average of 3 weeks.
Changes in waveform peak will be observed per each variable application of LIFU
Outcomes assessed throughout 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)

August 26, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21-892

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

Yes

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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