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

Not Applicable

Completed

• Conditions: Healthy Young Adults
• Interventions: Device: TMS; Device: Sham

• Registration Number: NCT06043076
• Lead Sponsor: Universiti Putra Malaysia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active then sham stimulation	TMS	Active iTBS over the left M1 hand region, followed after 1 week washout period by sham iTBS over the left M1 hand region
Sham then active stimulation	TMS	Sham iTBS over the left M1 hand region, followed after 1 week washout period by active iTBS over the left M1 hand region
Active then sham stimulation	Sham	Active iTBS over the left M1 hand region, followed after 1 week washout period by sham iTBS over the left M1 hand region
Sham then active stimulation	Sham	Sham iTBS over the left M1 hand region, followed after 1 week washout period by active iTBS over the left M1 hand region

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Heart rate	Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes	Heart rate (bpm) using semi-automated oscillometric sphygmomanometer
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
Baseline corticospinal excitability indices	Baseline	Test-retest reliability of resting motor threshold (RMT) and MEP amplitude

Trial Locations

Locations (1)

Hospital Sultan Abdul Aziz Shah; 🇲🇾 Serdang, Selangor, Malaysia