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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06043076
Other study ID # JKEUPM-2023-674
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date January 1, 2024

Study information

Verified date April 2024
Source Universiti Putra Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date January 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Malaysia Hospital Sultan Abdul Aziz Shah Serdang Selangor

Sponsors (1)

Lead Sponsor Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary TMSens_Q questionnaire Self-reported side effects using structured TMSens_Q questionnaire to evaluate the tolerability of iTBS At the end of every session
Secondary Blood glucose Capillary blood glucose using portable glucometer Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes
Secondary 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
Secondary Heart rate Heart rate (bpm) using semi-automated oscillometric sphygmomanometer Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes
Secondary Baseline corticospinal excitability indices Test-retest reliability of resting motor threshold (RMT) and MEP amplitude Baseline
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