iTBS Effect on M1 Plasticity, Blood Glucose, and Cardiovascular Response

Study Overview
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Brief Summary
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Transcranial magnetic stimulation is a medical device that can alter motor cortical (M1) excitability through the scalp via various protocols. Among these, intermittent theta-burst stimulation (iTBS) is a novel protocol that enhances the M1 excitability for several minutes beyond stimulation. The changes in M1 excitability might in turn be accompanied by other physiological responses in the human body. This study will explore the effect of iTBS protocol on M1 plasticity, heart rate, blood pressure, and blood glucose in healthy young adults in comparison to sham stimulation.

Official Title
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The Effect of Intermittent Theta-Burst Stimulation on Motor Cortical Plasticity, Blood Glucose, and Cardiovascular Response in Healthy Young Adults

Conditions
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Healthy Young Adults

Intervention / Treatment
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* Device: TMS
* Device: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy young adults (18-35 years old) Right-handed Fully vaccinated against COVID-19 Exclusion criteria: Subjects with contraindications to TMS based on the screening 13-item questionnaire for TMS candidacy Smokers Obese (BMI ≥ 30) Highly active subjects Active or previous lab-confirmed COVID-19 with long symptoms

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active then sham stimulation<br>Active iTBS over the left M1 hand region, followed after 1 week washout period by sham iTBS over the left M1 hand region | Device: TMS<br>* Active iTBS will be applied using a butterfly figure-of-eight C-B60 coil connected to MagPro R30 stimulator with add-on Theta Burst option (MagVenture A/S, Farum, Denmark).<br>Device: Sham<br>* Sham iTBS will be applied using acoustic stimulation of a second coil behind the participant's head<br>|
| Experimental: Sham then active stimulation<br>Sham iTBS over the left M1 hand region, followed after 1 week washout period by active iTBS over the left M1 hand region | Device: TMS<br>* Active iTBS will be applied using a butterfly figure-of-eight C-B60 coil connected to MagPro R30 stimulator with add-on Theta Burst option (MagVenture A/S, Farum, Denmark).<br>Device: Sham<br>* Sham iTBS will be applied using acoustic stimulation of a second coil behind the participant's head<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor evoked potential (MEP) | Peak-to-peak MEP amplitude elicited by single-pulse TMS over the left M1 representation of the first dorsal interosseous (FDI) muscle. In each MEP measurement throughout the study, a total of 12 MEP readings, elicited by single pulse TMS at an intensity of 120% resting motor threshold, and separated by 15 seconds, will be collected. In each time point post-iTBS, the mean value of MEPs (aka, conditioned MEPs) will be averaged and compared to pre-iTBS (aka, baseline MEPs) using the following equation: (conditioned MEP amplitude/baseline MEP amplitude) × 100. A value of 90-110% represents no change, while values < 90% represent suppression, and > 110% represent facilitation of the M1 plasticity following iTBS. | Pre-iTBS (baseline) and post-iTBS at 5,10,20, and 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TMSens_Q questionnaire | Self-reported side effects using structured TMSens_Q questionnaire to evaluate the tolerability of iTBS | At the end of every session | 
| Blood glucose | Capillary blood glucose using portable glucometer | Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes | 
| Blood pressure | Systolic blood pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) using semi-automated oscillometric sphygmomanometer. Unit of measure: mmHg | Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes | 
| Heart rate | Heart rate (bpm) using semi-automated oscillometric sphygmomanometer | Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes | 
| Baseline corticospinal excitability indices | Test-retest reliability of resting motor threshold (RMT) and MEP amplitude | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, Transcranial magnetic stimulation (TMS), Intermittent theta-burst stimulation (iTBS), Primary motor cortex (M1), Neuroplasticity, Heart rate, Blood pressure, Blood glucose, Young adults