Healthy Young Adults
Conditions
Keywords
Transcranial magnetic stimulation (TMS), Intermittent theta-burst stimulation (iTBS), Primary motor cortex (M1), Neuroplasticity, Heart rate, Blood pressure, Blood glucose, Healthy, Young adults
Brief summary
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.
Interventions
DEVICETMS
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).
DEVICESham
Sham iTBS will be applied using acoustic stimulation of a second coil behind the participant's head
Sponsors
Universiti Putra Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor evoked potential (MEP) | Pre-iTBS (baseline) and post-iTBS at 5,10,20, and 30 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TMSens_Q questionnaire | At the end of every session | Self-reported side effects using structured TMSens\_Q questionnaire to evaluate the tolerability of iTBS |
| Blood glucose | Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes | Capillary blood glucose using portable glucometer |
| Blood pressure | Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes | Systolic blood pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) using semi-automated oscillometric sphygmomanometer. Unit of measure: mmHg |
| Heart rate | Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes | Heart rate (bpm) using semi-automated oscillometric sphygmomanometer |
| Baseline corticospinal excitability indices | Baseline | Test-retest reliability of resting motor threshold (RMT) and MEP amplitude |
Countries
Malaysia
Outcome results
None listed