Ultrasound Effects on Human Motor Cortical Plasticity

University of Virginia80 enrolled

Overview

The purpose of this study is to test the duration and effect of single element focused ultrasound to the primary motor cortex on healthy human participants with the use of transcranial focused ultrasound and transcranial magnetic stimulation.

Previous research has shown ultrasound to inhibit motor cortical excitability though it is currently not known how long these effects last. This is an important consideration if ultrasound is to be translated and advanced to clinical or therapeutic uses as this study will help to determine suitable ultrasound durations for efficacious use. The investigators will test the duration of ultrasound neuromodulation using transcranial magnetic stimulation which will elicit a recordable and quantifiable metric of motor cortical excitability in the form of a motor evoked potential. Participants will complete 3 study visits. During the first study visit, participants will complete Magnetic Resonance Imaging and Computed Tomography scans for TUMS localization in visits 2 and 3. Each participant will undergo motor cortex thresholding prior to their study TUMS stimulation procedure. Depending on randomization, subjects may receive one or two TUMS stimulation procedures at each session.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Healthy Participants

Interventions

Transcranial Ultrasound Magnetic StimulationOTHER

Transcranial Ultrasound Magnetic Stimulation is a paradigm that allows for concurrent and concentric ultrasound stimulation with transcranial magnetic stimulation (TMS).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy, adult subject * 18-65 years of age * Provided informed consent Exclusion Criteria: * Presence of a significant medical, psychiatric, or neurologic illness * History of loss of consciousness of more than ten minutes in the past year or loss of consciousness in a lifetime that required rehabilitation services * Personal or family history of seizure * Any history of stroke/transient ischemic attack (TIA) or severe traumatic brain injury * Taking any medications that may decrease the threshold for seizure * Pregnancy (self-reported) * Affirmative answers to one or more questions of the provided attached safety questionnaires. These are not absolute contraindications to this study but the risk/benefit ratio will be carefully balanced by the PI * Failure to follow laboratory or study procedures

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

Change in Motor Evoked Potential Amplitude

The effect of ultrasound will be measured by comparing MEP amplitude changes after TUMS compared to baseline. Baseline MEPs will be collected at the beginning of each session and changes in MEP amplitude will be measured directly after with TUMS.

Time frame: baseline and immediately following the TUMS stimulation

Central Contacts

Sarah Adams

CONTACT

434-243-4319 neuromodlab@hscmail.mcc.virginia.edu

Data from ClinicalTrials.gov

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