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

NCT ID: NCT04019028

Last Updated: 2020-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-12

Study Completion Date

2019-08-16

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,

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Navigated low frequency rTMS

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.

Group Type EXPERIMENTAL

low frequency rTMS + Navigation System

Intervention Type DEVICE

1Hz low-frequency rTMS stimulation over primary motor area using navigation system

only low frequency rTMS(not using Navigation System)

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.

Group Type EXPERIMENTAL

only low frequency rTMS

Intervention Type DEVICE

1Hz low-frequency rTMS stimulation over primary motor area

Navigated Sham rTMS

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

Group Type SHAM_COMPARATOR

Sham low frequency rTMS + Navigation System

Intervention Type DEVICE

1Hz low-frequency sham rTMS stimulation over primary motor area using navigation system

Interventions

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low frequency rTMS + Navigation System

1Hz low-frequency rTMS stimulation over primary motor area using navigation system

Intervention Type DEVICE

only low frequency rTMS

1Hz low-frequency rTMS stimulation over primary motor area

Intervention Type DEVICE

Sham low frequency rTMS + Navigation System

1Hz low-frequency sham rTMS stimulation over primary motor area using navigation system

Intervention Type DEVICE

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yun-Hee Kim

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yun-Hee Kimm, MD, PhD

Role: STUDY_CHAIR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2014-05-021

Identifier Type: -

Identifier Source: org_study_id

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