Study Stopped
The study was terminated due to difficulty in recruiting subjects
Individualized Transcranial Direct Current Stimulation for Gait Function in Healthy Subjects
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
1 active site
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 21, 2019
CompletedFirst Posted
Study publicly available on registry
July 24, 2019
CompletedStudy Start
First participant enrolled
August 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2019
CompletedSeptember 23, 2019
September 1, 2019
24 days
July 21, 2019
September 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
10 meter walk test (10MWT)
Before stimulation (baseline); After strimulation during 30 min
Timed Up and Go test (TUG)
Before stimulation (baseline); After strimulation during 30 min
Gait analysis using surface electromyograph
Before stimulation (baseline); After strimulation during 30 min
Gait analysis using motion analysis system
Before stimulation (baseline); After strimulation during 30 min
Study Arms (2)
Individualized stimulation group
EXPERIMENTALBased on transcranial direct current stimulation (tDCS) simulation, individualized stimulation on leg motor areas during 30 minutes.
Conventional stimulation group
ACTIVE COMPARATORConventional stimulation on leg motor areas during 30 minutes.
Interventions
Based on tDCS stimulation, individualized stimulation during 30 minutes with sitting position.
Conventional tDCS stimulation during 30 minutes with sitting position.
Eligibility Criteria
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, 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Yun-Hee Kim, MD, PhD
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2019
First Posted
July 24, 2019
Study Start
August 5, 2019
Primary Completion
August 29, 2019
Study Completion
August 29, 2019
Last Updated
September 23, 2019
Record last verified: 2019-09