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

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

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 Overview

• Status: Completed
• Conditions: Healthy Young Adults
• Intervention / Treatment: Device: TMS; Device: Sham

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Serdang, Selangor, Malaysia, 43400
      • Hospital Sultan Abdul Aziz Shah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active then sham stimulation; Active iTBS over the left M1 hand region, followed after 1 week washout period by sham iTBS over the left M1 hand region	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).; Device: Sham; Sham iTBS will be applied using acoustic stimulation of a second coil behind the participant's head
Experimental: Sham then active stimulation; Sham iTBS over the left M1 hand region, followed after 1 week washout period by active iTBS over the left M1 hand region	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).; Device: Sham; Sham iTBS will be applied using acoustic stimulation of a second coil behind the participant's head

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
TMSens_Q questionnaire	Self-reported side effects using structured TMSens_Q questionnaire to evaluate the tolerability of iTBS	At the end of every session
Blood glucose	Capillary blood glucose using portable glucometer	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	Pre-iTBS (baseline) and post-iTBS at 0 and 30 minutes
Heart rate	Heart rate (bpm) using semi-automated oscillometric sphygmomanometer	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	Baseline

Collaborators and Investigators

• Sponsor: Universiti Putra Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Neuroplasticity; Healthy; Blood pressure; Transcranial magnetic stimulation (TMS); Young adults; Heart rate; Blood glucose; Intermittent theta-burst stimulation (iTBS); Primary motor cortex (M1)
• Other Study ID Numbers: JKEUPM-2023-674

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified raw datasets collected during the trial will be freely available upon completion on the Open Science Framework repository at https://osf.io/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No