Real-time Monitoring of Motor Cortical Activity Induced by Low-frequency Repetitive Transcranial Magnetic Stimulation

Study Overview
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Brief Summary
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In this study, we investigated the effect of low-frequency repetitive trans cranial magnetic stimulation, one of the noninvasive brain stimuli, on the functional changes of the bilateral motor cortical activity in normal subjects using functional near infrared spectroscopy (fNIRS).

Detailed Description
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In normal subjects, the effect of low-frequency repetitive transcranial magnetic stimulation on cerebral cortex are measured in real time using fNIRS. Changes in cerebral cortical activity before and after stimulation are measured using the motor function test and the motor-induced potential test

Official Title
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Real-time Monitoring of Motor Cortical Activity Induced by Low-frequency Repetitive Transcranial Magnetic Stimulation: Functional Near Infrared Spectroscopic Study

Conditions
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Healthy

Intervention / Treatment
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* Device: low frequency rTMS + Navigation System
* Device: only low frequency rTMS
* Device: Sham low frequency rTMS + Navigation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult men and women without history of central nervous system disease and abnormalities Exclusion Criteria: Under 18 years old, 70 years old or older A person who has inserted a metal object in a skull A person with complete occlusion of the carotid artery A person with epilepsy Pregnant and lactating women Who is not eligible for the test

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navigated low frequency rTMS<br>Application of 1Hz low frequency repetitive transcranial magnetic stimulation to the primary motor area of the dominant hemisphere using a navigation system. Using the BrainSight instrument, a navigation system, the TMS coil position can be fixed on the point precise target area based on the subject's MRI image. | Device: low frequency rTMS + Navigation System<br>* 1Hz low-frequency rTMS stimulation over primary motor area using navigation system<br>|
| Experimental: only low frequency rTMS(not using Navigation System)<br>Application of low frequency repetitive transcranial magnetic stimulation to the primary motor area of the dominant hemisphere not using a navigation system. TMS coil is fixed on the target area based on MEP hotspot. | Device: only low frequency rTMS<br>* 1Hz low-frequency rTMS stimulation over primary motor area<br>|
| Sham Comparator: Navigated Sham rTMS<br>Application of repetitive transcranial magnetic stimulation with sham mode(no stimulation) to the primary motor area of the dominant hemisphere using a navigation system. Using the BrainSight instrument, a navigation system, the TMS coil position can be fixed on the point precise target area based on the subject's MRI image. Sham stimulation is stimulated by the same frequency, intensity and time as the actual stimulus in such a way that the 8-shaped coil is placed at a 90 degree angle to the scalp in the same manner as rTMS and sounds are heard but the magnetic stimulus is not transmitted to the cerebrum | Device: Sham low frequency rTMS + Navigation System<br>* 1Hz low-frequency sham rTMS stimulation over primary motor area using navigation system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Cortical activation | Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) before and after stimulation | Baseline and after intervention[Immediately after 20 minutes of intervention] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in motor evoked potentia | measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle. | Baseline and after intervention[Immediately after 20 minutes of intervention] | 
| changes in nine hole peg test | Nine-Hole Peg Test is used to measure finger dexterity in patients with various neurological diagnoses. | Baseline and after intervention[Immediately after 20 minutes of intervention] | 
| Sequential motor task | It is a training exercise in which five digits are repeatedly pressed with five fingers using individual movements, and it is trained to press the button accurately and quickly. | Baseline and after intervention[Immediately after 20 minutes of intervention] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low frequency rTMS, fNIRS, Hemodynamic Response, Non-invasive brain stimulation