NCT04019028

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

July 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2019

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

1 month

First QC Date

July 11, 2019

Last Update Submit

February 25, 2020

Conditions

Healthy

Keywords

low frequency rTMSfNIRSHemodynamic ResponseNon-invasive brain stimulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Changes in motor evoked potentia

    Baseline and after intervention[Immediately after 20 minutes of intervention]

  • changes in nine hole peg test

    Baseline and after intervention[Immediately after 20 minutes of intervention]

  • Sequential motor task

    Baseline and after intervention[Immediately after 20 minutes of intervention]

Study Arms (3)

Navigated low frequency rTMS

EXPERIMENTAL

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

only low frequency rTMS(not using Navigation System)

EXPERIMENTAL

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

Navigated Sham rTMS

SHAM COMPARATOR

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

Interventions

low frequency rTMS + Navigation SystemDEVICE

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

Navigated low frequency rTMS
only low frequency rTMSDEVICE

1Hz low-frequency rTMS stimulation over primary motor area

only low frequency rTMS(not using Navigation System)
Sham low frequency rTMS + Navigation SystemDEVICE

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

Navigated Sham rTMS

Eligibility Criteria

Age19 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult men and women without history of central nervous system disease and abnormalities

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Study Officials

  • Yun-Hee Kimm, MD, PhD

    Samsung Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

July 11, 2019

First Posted

July 15, 2019

Study Start

July 12, 2019

Primary Completion

August 16, 2019

Study Completion

August 16, 2019

Last Updated

February 27, 2020

Record last verified: 2020-02

Locations

KR(1)