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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04019028
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 3
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 8.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: low frequency rTMS + Navigation System; Device: only low frequency rTMS; Device: Sham low frequency rTMS + Navigation System	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Real-time Monitoring of Motor Cortical Activity Induced by Low-frequency Repetitive Transcranial Magnetic Stimulation: Functional Near Infrared Spectroscopic Study
• Actual Study Start Date: Jul 12, 2019
• Actual Primary Completion Date: Aug 16, 2019
• Actual Study Completion Date: Aug 16, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yun-Hee Kim, Professor, MD, PhD, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT04019028
• Other Study ID Numbers: 2014-05-021
• First Posted: Jul 15, 2019
• Last Update Posted: Feb 27, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yun-Hee Kim, Professor, MD, PhD, Samsung Medical Center: low frequency rTMS; fNIRS; Hemodynamic Response; Non-invasive brain stimulation

Study Results

No Results Posted as of Feb 27, 2020