The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy

Study Overview
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Brief Summary
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The purpose of this research study is to determine whether brain anatomy impacts the efficacy of transcranial magnetic stimulation (TMS) which is a form of non-invasive brain stimulation. TMS is used to stimulate different areas of the brain and it is well tolerated and generally a safe procedure. It has been studied by researchers for 20 plus years. This brain stimulation device and technique used in this study is an investigational device that has not been approved by the U.S. FDA for treating any muscle or nerve problems. A copy of the device brochure can be found at: https://www.magstim.com/product/rapid-family/

Official Title
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The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy

Conditions
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Healthy

Intervention / Treatment
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* Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle
* Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: nonimpaired individuals free of contraindications for MRI and TMS Exclusion Criteria: musculoskeletal injury of the arm neurologic deficit affecting motor or sensory function concurrent severe medical illness diagnosis of SARS-CoV2, or symptoms consistent with COVID-19, or close contact with someone with SARS-CoV2 in the past 3 weeks

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain stimulation over bicep muscle than finger (FDI) muscle.<br>Brain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups. | Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle<br>* repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head<br>Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle<br>* repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head<br>|
| Experimental: Brain stimulation over than finger (FDI) muscle than bicep muscle.<br>Brain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups. | Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle<br>* repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head<br>Device: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle<br>* repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Corticomotor Excitability With Active Stimulation on Bicep Muscle | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability | approximately 7 days | 
| Change in Corticomotor Excitability With Sham Stimulation on Bicep Muscle | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability | approximately 7 days | 
| Change in Corticomotor Excitability With Active Stimulation on Finger Muscle | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability | approximately 7 days | 
| Change in Corticomotor Excitability With Sham Stimulation on Finger Muscle | The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability | approximately 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial magnetic stimulation, non-invasive brain stimulation, magnetic resonance imaging