Investigation of the Duration of Low-intensity Focused Ultrasound

NCT ID: NCT05147103

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-26

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Development of LIFU for Clinical Purposes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Multi-visit study, testing various LIFU durations
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Low-Intensity Focused Ultrasound

Intervention Type DEVICE

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

Interventions

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Low-Intensity Focused Ultrasound

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Virginia Polytechnic Institute and State University

OTHER

Sponsor Role lead

Responsible Party

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Wynn Legon

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fralin Biomedical Research Institute

Roanoke, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 29968768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29380485 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24413698 (View on PubMed)

Other Identifiers

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21-892

Identifier Type: -

Identifier Source: org_study_id

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