Investigation of Low-intensity Focused Ultrasound Parameters

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 Overview

• Status: Completed
• Conditions: Development of LIFU for Clinical Purposes
• Intervention / Treatment: Device: Low-intensity Focused Ultrasound

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Fralin Biomedical Research Institute

Participation Criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parameter Trials; Approximately 36 parameter combinations will be tested per study session, expected 6 sessions of trials. Response recorded using TMS and EMG.	Device: Low-intensity Focused Ultrasound; LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University

Publications and helpful links

General Publications

• 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: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.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): March 11, 2024
• Study Completion (Actual): March 11, 2024

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: transcranial magnetic stimulation; low-intensity focused ultrasound
• Other Study ID Numbers: 21-882

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