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

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: low frequency rTMS + Navigation System; Device: only low frequency rTMS; Device: Sham low frequency rTMS + Navigation System

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: low frequency rTMS + Navigation System; 1Hz low-frequency rTMS stimulation over primary motor area using navigation system
EXPERIMENTAL: 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.	Device: only low frequency rTMS; 1Hz low-frequency rTMS stimulation over primary motor area
SHAM_COMPARATOR: 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	Device: Sham low frequency rTMS + Navigation System; 1Hz low-frequency sham rTMS stimulation over primary motor area using navigation system

What is the study measuring?

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]

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Study Chair: Yun-Hee Kimm, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 12, 2019
• Primary Completion (ACTUAL): August 16, 2019
• Study Completion (ACTUAL): August 16, 2019

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (ACTUAL): July 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: fNIRS; Non-invasive brain stimulation; low frequency rTMS; Hemodynamic Response
• Other Study ID Numbers: 2014-05-021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No