Ultrasound Effects on Human Motor Cortical Plasticity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ultrasound Effects on Human Motor Cortical Plasticity

Conditions
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Healthy Participants

Intervention / Treatment
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* Other: Transcranial Ultrasound Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomized into two groups. Group A will receive a two part Transcranial Ultrasound Magnetic Stimulation (TUMS) on two visits and Group B will receive a one part TUMS on two visits.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TUMS and Sham Group<br>During the subjects two visits they will receive a TUMS stimulation and a sham (placebo) stimulation at both visits. | Other: Transcranial Ultrasound Magnetic Stimulation<br>* Transcranial Ultrasound Magnetic Stimulation is a paradigm that allows for concurrent and concentric ultrasound stimulation with transcranial magnetic stimulation (TMS).<br>|
| Experimental: TUMS or Sham Group<br>During the subjects first of two visits they will receive either a TUMS stimulation or a sham (placebo) stimulation and at the second visit they will receive the other. | Other: Transcranial Ultrasound Magnetic Stimulation<br>* Transcranial Ultrasound Magnetic Stimulation is a paradigm that allows for concurrent and concentric ultrasound stimulation with transcranial magnetic stimulation (TMS).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and immediately following the TUMS stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Neuromodulation, Transcranial Magnetic Stimulation, Transcranial Ultrasound Stimulation