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

Healthy Young Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06043076
• Other study ID #: JKEUPM-2023-674
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Healthy Young Adults

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