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Completed

NCT Number: NCT06043076

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

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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Key information

Conditions

Healthy Young Adults

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sultan Abdul Aziz Shah

Serdang, Selangor, 43400, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

SHAM

Device

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

Primary outcomes

  1. Motor evoked potential (MEP)

    Time frame: 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 outcomes

  1. TMSens_Q questionnaire

    Time frame: At the end of every session

    Self-reported side effects using structured TMSens_Q questionnaire to evaluate the tolerability of iTBS

  2. Blood glucose

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

    Capillary blood glucose using portable glucometer

  3. Blood pressure

    Time frame: 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

  4. Heart rate

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

    Heart rate (bpm) using semi-automated oscillometric sphygmomanometer

  5. Baseline corticospinal excitability indices

    Time frame: Baseline

    Test-retest reliability of resting motor threshold (RMT) and MEP amplitude

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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