Investigation of the Duration of Low-intensity Focused Ultrasound

NCT05147103 | Enrolling By Invitation FDA Device

• 1 other identifier: 21-892
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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

  Outcomes assessed throughout participation - an average of 3 weeks.

Study Arms (1)

Duration Trials

EXPERIMENTAL

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

Interventions

Low-Intensity Focused Ultrasound DEVICE

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

Duration 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

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

• Legon W, Ai L, Bansal P, Mueller JK. Neuromodulation with single-element transcranial focused ultrasound in human thalamus. Hum Brain Mapp. 2018 May;39(5):1995-2006. doi: 10.1002/hbm.23981. Epub 2018 Jan 29.

  PMID: 29380485 BACKGROUND

• Legon W, Sato TF, Opitz A, Mueller J, Barbour A, Williams A, Tyler WJ. Transcranial focused ultrasound modulates the activity of primary somatosensory cortex in humans. Nat Neurosci. 2014 Feb;17(2):322-9. doi: 10.1038/nn.3620. Epub 2014 Jan 12.

  PMID: 24413698 BACKGROUND

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 durations

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 7, 2021
• Study Start: August 26, 2022
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)