Investigation of Low-intensity Focused Ultrasound Parameters

• Sponsor: Virginia Polytechnic Institute and State University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05134233
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 23.6
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

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 parameters per sessionMulti-visit study, testing various LIFU parameters per session
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Investigation of Low-intensity Focused Ultrasound Parameters
• Actual Study Start Date: Jan 14, 2022
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Waveforms [Outcome measured throughout study participation - an average of 4 weeks per participant.]

   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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fralin Biomedical Research Institute	Roanoke	Virginia	United States	24016

Sponsors and Collaborators

• Virginia Polytechnic Institute and State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. pii: e54497. doi: 10.7554/eLife.54497.
• 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.
• 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.

• Responsible Party: Wynn Legon, Assistant Professor, Virginia Polytechnic Institute and State University
• ClinicalTrials.gov Identifier: NCT05134233
• Other Study ID Numbers: 21-882
• First Posted: Nov 24, 2021
• Last Update Posted: Mar 4, 2022
• Last Verified: Feb 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 Mar 4, 2022