Investigation of Low-intensity Focused Ultrasound Parameters

NCT05134233 | Completed Results

• 1 other identifier: 21-882
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Development of LIFU for Clinical Purposes

Keywords

low-intensity focused ultrasound; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Parameter Trials

EXPERIMENTAL

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

Interventions

Low-intensity Focused Ultrasound DEVICE

LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG.

Parameter Trials

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above criteria and must understand and speak English.

You may not qualify if:

• Contraindications to MRI, CT, or TMS
• Claustrophobia
• Pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
• 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 a social security number or tax ID number. This is required for tax purposes or payment cannot be processed.

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

Location

Related Publications (3)

• 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.

  PMID: 29968768 BACKGROUND

• 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.

  PMID: 33236981 BACKGROUND

• 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.

  PMID: 34487826 BACKGROUND

Results Point of Contact

• Title: Jessica Florig
• Organization: Fralin Biomedical Research Institute at VTC

jnw@vtc.vt.edu

540-526-2261

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Multi-visit study, testing various LIFU parameters per session

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 24, 2021
• Study Start: January 14, 2022
• Primary Completion: March 11, 2024
• Study Completion: March 11, 2024
• Last Updated: January 23, 2025
• Results First Posted: January 23, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)