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Completed

NCT Number: NCT04019028

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

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).

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Key information

Conditions

Healthy

Age range

19 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low frequency rTMS + Navigation System

Device

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

only low frequency rTMS

Device

1Hz low-frequency rTMS stimulation over primary motor area

Sham low frequency rTMS + Navigation System

Device

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

Primary outcomes

  1. Changes of Cortical activation

    Time frame: 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 outcomes

  1. Changes in motor evoked potentia

    Time frame: 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.

  2. changes in nine hole peg test

    Time frame: 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.

  3. Sequential motor task

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 15, 2019
Registry last updated
Feb 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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