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

Sponsor

Universiti Putra Malaysia (Other)

Overall Status

Recruiting

CT.gov ID

NCT06043076

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Young Adults	Device: TMS Device: Sham	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Motor evoked potential (MEP) [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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