Investigation of Low-intensity Focused Ultrasound Parameters

Overview

This project examines the effects of different brain stimulation settings 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, an fMRI and 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 on the hand.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2024

Interventions

  • Device: Low-intensity Focused Ultrasound
    • LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG.

Arms, Groups and Cohorts

  • Experimental: Parameter Trials
    • Approximately 36 parameter combinations will be tested per study session, expected 6 sessions of trials. Response recorded using TMS and EMG.

Clinical Trial Outcome Measures

Primary Measures

  • Waveforms
    • Time Frame: Outcome measured throughout study participation – an average of 4 weeks per participant.
    • Changes in waveform peak will be observed per each variable application of LIFU

Participating in This Clinical Trial

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 8. Failure to provide a social security number or tax ID number. This is required for tax purposes or payment cannot be processed.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Virginia Polytechnic Institute and State University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wynn Legon, Assistant Professor – Virginia Polytechnic Institute and State University
  • Overall Contact(s)
    • Wynn Legon, PhD, 540-526-2184, wlegon@vtc.vt.edu

References

Legon W, Bansal P, Tyshynsky R, Ai L, Mueller JK. Transcranial focused ultrasound neuromodulation of the human primary motor cortex. Sci Rep. 2018 Jul 3;8(1):10007. doi: 10.1038/s41598-018-28320-1.

Fomenko A, Chen KS, Nankoo JF, Saravanamuttu J, Wang Y, El-Baba M, Xia X, Seerala SS, Hynynen K, Lozano AM, Chen R. Systematic examination of low-intensity ultrasound parameters on human motor cortex excitability and behavior. Elife. 2020 Nov 25;9. pii: e54497. doi: 10.7554/eLife.54497.

Xia X, Fomenko A, Nankoo JF, Zeng K, Wang Y, Zhang J, Lozano AM, Chen R. Time course of the effects of low-intensity transcranial ultrasound on the excitability of ipsilateral and contralateral human primary motor cortex. Neuroimage. 2021 Nov;243:118557. doi: 10.1016/j.neuroimage.2021.118557. Epub 2021 Sep 4.

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