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

NCT06043076 | Completed DMC

• 1 other identifier: JKEUPM-2023-674
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Young Adults

Keywords

Transcranial magnetic stimulation (TMS); Intermittent theta-burst stimulation (iTBS); Primary motor cortex (M1); Neuroplasticity; Heart rate; Blood pressure; Blood glucose; Healthy; Young adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• TMSens_Q questionnaire

  At the end of every session

• Blood glucose

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

• Blood pressure

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

• Heart rate

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

• Baseline corticospinal excitability indices

  Baseline

Study Arms (2)

Active then sham stimulation

EXPERIMENTAL

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; Device: Sham

Sham then active stimulation

EXPERIMENTAL

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; Device: Sham

Interventions

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).

Active then sham stimulation; Sham then active stimulation

Sham DEVICE

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

Active then sham stimulation; Sham then active stimulation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy young adults (18-35 years old)
• Right-handed
• Fully vaccinated against COVID-19

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Hospital Sultan Abdul Aziz Shah

Serdang, Selangor, 43400, Malaysia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 21, 2023
• Study Start: July 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

MY (1)