Investigation of the Duration of Low-intensity Focused Ultrasound

• Sponsor: Virginia Polytechnic Institute and State University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05147103
• Collaborator: (none)
• Enrollment: 80
• Arm: 1
• Anticipated Duration (Months): 17

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Development of LIFU for Clinical Purposes	Device: Low-Intensity Focused Ultrasound	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Multi-visit study, testing various LIFU durationsMulti-visit study, testing various LIFU durations
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Investigation of the Duration of Low-intensity Focused Ultrasound
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Low-Intensity Focused Ultrasound; LIFU application using various durations, responses of neuromodulation recorded using TMS and EMG.

Outcome Measures

Primary Outcome Measures

1. Waveforms [Outcomes assessed throughout participation - an average of 3 weeks.]

   Changes in waveform peak will be observed per each variable application of LIFU

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Virginia Polytechnic Institute and State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Wynn Legon, Assistant Professor, Virginia Polytechnic Institute and State University
• ClinicalTrials.gov Identifier: NCT05147103
• Other Study ID Numbers: 21-892
• First Posted: Dec 7, 2021
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wynn Legon, Assistant Professor, Virginia Polytechnic Institute and State University: low-intensity focused ultrasound; transcranial magnetic stimulation

Study Results

No Results Posted as of Jul 28, 2022