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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: only low frequency rTMS; Device: low frequency rTMS + Navigation System; Device: Sham low frequency rTMS + Navigation System

• Registration Number: NCT04019028
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

In normal subjects,

1. the effect of low-frequency repetitive transcranial magnetic stimulation on cerebral cortex are measured in real time using fNIRS.

2. Changes in cerebral cortical activity before and after stimulation are measured using the motor function test and the motor-induced potential test

Study Timeline

• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-11
• Study Start: 2019-07-12
• Study First Posted: 2019-07-15
• Primary Completion: 2019-08-16
• Study Completion: 2019-08-16
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
only low frequency rTMS(not using Navigation System)	only low frequency rTMS	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.
Navigated low frequency rTMS	low frequency rTMS + Navigation System	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.
Navigated Sham rTMS	Sham low frequency rTMS + Navigation System	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
changes in nine hole peg test	Baseline and after intervention[Immediately after 20 minutes of intervention]	Nine-Hole Peg Test is used to measure finger dexterity in patients with various neurological diagnoses.
Sequential motor task	Baseline and after intervention[Immediately after 20 minutes of intervention]	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.
Changes in motor evoked potentia	Baseline and after intervention[Immediately after 20 minutes of intervention]	measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of