Individualized Transcranial Direct Current Stimulation for Gait Function in Healthy Subjects

The purpose of this study is to compare the effects of individualized brain stimulation based on simulation and conventional brain stimulation in healthy adults.

Study Overview

• Status: Terminated
• Conditions: Healthy Aging; Healthy Adults
• Intervention / Treatment: Device: Individualized transcranial direct current stimulation; Device: Conventional transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Actual): 19
• 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 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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, 75 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: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individualized stimulation group; Based on transcranial direct current stimulation (tDCS) simulation, individualized stimulation on leg motor areas during 30 minutes.	Device: Individualized transcranial direct current stimulation; Based on tDCS stimulation, individualized stimulation during 30 minutes with sitting position.
Active Comparator: Conventional stimulation group; Conventional stimulation on leg motor areas during 30 minutes.	Device: Conventional transcranial direct current stimulation; Conventional tDCS stimulation during 30 minutes with sitting position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cortical activation	changes in cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.	Change from baseline (before stimulation) after stimulation during 30 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 meter walk test (10MWT)	Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."	Before stimulation (baseline); After strimulation during 30 min
Timed Up and Go test (TUG)	The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.	Before stimulation (baseline); After strimulation during 30 min
Gait analysis using surface electromyograph	Gait analysis is a process of measuring and evaluating the walking patterns of patients by using surface electromyograph.	Before stimulation (baseline); After strimulation during 30 min
Gait analysis using motion analysis system	Gait analysis is a process of measuring and evaluating the walking patterns of patients by using motion analysis system.	Before stimulation (baseline); After strimulation during 30 min

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Actual): August 29, 2019
• Study Completion (Actual): August 29, 2019

Study Registration Dates

• First Submitted: July 21, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Brain Stimulation; Transcranial direct current stimulation; Motor function
• Other Study ID Numbers: 2018-11-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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