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

University of Putra Malaysia (UPM)

Status: Completed

Conditions: Healthy Young Adults

Treatments: Device: Sham; Device: TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT06043076

JKEUPM-2023-674

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Active then sham stimulation

Experimental group

Description:

Active iTBS over the left M1 hand region, followed after 1 week washout period by sham iTBS over the left M1 hand region

Treatment:

Device: Sham

Device: TMS

Sham then active stimulation

Experimental group

Description:

Sham iTBS over the left M1 hand region, followed after 1 week washout period by active iTBS over the left M1 hand region

Treatment:

Device: Sham

Device: TMS