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

Universiti Putra Malaysia18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Healthy Young Adults

Interventions

TMSDEVICE

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).

ShamDEVICE

Sham iTBS will be applied using acoustic stimulation of a second coil behind the participant's head

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hospital Sultan Abdul Aziz Shah

Serdang, Selangor, Malaysia

Outcomes

Primary Outcomes

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.

Time frame: Pre-iTBS (baseline) and post-iTBS at 5,10,20, and 30 minutes

Secondary Outcomes

TMSens_Q questionnaire

Self-reported side effects using structured TMSens\_Q questionnaire to evaluate the tolerability of iTBS

Time frame: At the end of every session

Blood glucose

Capillary blood glucose using portable glucometer

Time frame: 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

Time frame: Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes

Heart rate

Heart rate (bpm) using semi-automated oscillometric sphygmomanometer

Time frame: 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

Data from ClinicalTrials.gov

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