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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active then sham stimulation | Experimental | Active iTBS over the left M1 hand region, followed after 1 week washout period by sham iTBS over the left M1 hand region |
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| Sham then active stimulation | Experimental | Sham iTBS over the left M1 hand region, followed after 1 week washout period by active iTBS over the left M1 hand region |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS | Device | 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). |
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sultan Abdul Aziz Shah | Serdang | Selangor | 43400 | Malaysia |
Deidentified raw datasets collected during the trial will be freely available upon completion on the Open Science Framework repository at https://osf.io/
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| Sham | Device | Sham iTBS will be applied using acoustic stimulation of a second coil behind the participant's head |
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| 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 |