Individualized Transcranial Direct Current Stimulation for Gait Function in Healthy Subjects

Not Applicable

Terminated

• Conditions: Healthy Aging; Healthy Adults
• Interventions: Device: Conventional transcranial direct current stimulation; Device: Individualized transcranial direct current stimulation

• Registration Number: NCT04030793
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-21
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-24
• Study Start: 2019-08-05
• Primary Completion: 2019-08-29
• Study Completion: 2019-08-29
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional stimulation group	Conventional transcranial direct current stimulation	Conventional stimulation on leg motor areas during 30 minutes.
Individualized stimulation group	Individualized transcranial direct current stimulation	Based on transcranial direct current stimulation (tDCS) simulation, individualized stimulation on leg motor areas during 30 minutes.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Gait analysis using motion analysis system	Before stimulation (baseline); After strimulation during 30 min	Gait analysis is a process of measuring and evaluating the walking patterns of patients by using motion analysis system.
10 meter walk test (10MWT)	Before stimulation (baseline); After strimulation during 30 min	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."
Timed Up and Go test (TUG)	Before stimulation (baseline); After strimulation during 30 min	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.
Gait analysis using surface electromyograph	Before stimulation (baseline); After strimulation during 30 min	Gait analysis is a process of measuring and evaluating the walking patterns of patients by using surface electromyograph.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of