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NCT05134233 | Completed | Development of LIFU for Clinical Purposes

Investigation of Low-intensity Focused Ultrasound Parameters
Sponsor:

Virginia Polytechnic Institute and State University

Information provided by (Responsible Party):

Wynn Legon

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

Development of LIFU for Clinical Purposes

Intervention/treatment

Low-intensity Focused Ultrasound

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 23 participants
Masking : None (Open Label)
Primary Purpose : Basic Science
Official Title : Investigation of Low-intensity Focused Ultrasound Parameters
Actual Study Start Date : January 14, 2022
Estimated Primary Completion Date : March 11, 2024
Estimated Study Completion Date : March 11, 2024
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
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Above criteria and must understand and speak English.
Exclusion Criteria
  • 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.
Investigation of Low-intensity Focused Ultrasound Parameters

Location Details

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Investigation of Low-intensity Focused Ultrasound Parameters

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Virginia

Fralin Biomedical Research Institute

Roanoke, Virginia, United States, 24016