Healthy AdultsNCT04030793
Individualized Transcranial Direct Current Stimulation for Gait Function in Healthy Subjects
A study testing Individualized transcranial direct current stimulation and Conventional transcranial direct current stimulation in people with Healthy Adults and Healthy Aging, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults, Healthy Aging
- What is being tested?
- Individualized transcranial direct current stimulation and Conventional transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Aug 2019to 29 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult men and women without history of central nervous system disease and abnormalities
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the effects of individualized brain stimulation based on simulation and conventional brain stimulation in healthy adults.
- Conditions
- Healthy Adults, Healthy Aging
- Being tested
- Individualized transcranial direct current stimulation, Conventional transcranial direct current stimulation
- Keywords
- Brain Stimulation, Transcranial direct current stimulation, Motor function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized transcranial direct current stimulationDevice
Based on tDCS stimulation, individualized stimulation during 30 minutes with sitting position.
Conventional transcranial direct current stimulationDevice
Conventional tDCS stimulation during 30 minutes with sitting position.
| Study group | Role | What they receive |
|---|---|---|
| Individualized stimulation group | Experimental | Based on transcranial direct current stimulation (tDCS) simulation, individualized stimulation on leg motor areas during 30 minutes. Receives: Device: Individualized transcranial direct current stimulation |
| Conventional stimulation group | Active comparator | Conventional stimulation on leg motor areas during 30 minutes. Receives: Device: Conventional transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cortical activation
changes in cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
Measured: Change from baseline (before stimulation) after stimulation during 30 min
Secondary outcomes (4)
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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before stimulation (baseline); After strimulation during 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start5 Aug 2019
- Primary completion29 Aug 2019
- Study completion29 Aug 2019
Why it stopped: The study was terminated due to difficulty in recruiting subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun-Hee Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030793
- Sponsor's protocol ID
- 2018-11-021
- Status last verified
- Sep 2019
- First submitted
- 21 Jul 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Transcranial Direct Current Stimulation for Gait Function in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04030793
- Acronym / sponsor ID
- 2018-11-021
- Conditions
- Healthy Adults, Healthy Aging
- Keywords
- Brain Stimulation, Transcranial direct current stimulation, Motor function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to difficulty in recruiting subjects
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized stimulation group | Experimental | Device: Individualized transcranial direct current stimulationBased on transcranial direct current stimulation (tDCS) simulation, individualized stimulation on leg motor areas during 30 minutes. |
| Conventional stimulation group | Active comparator | Device: Conventional transcranial direct current stimulationConventional stimulation on leg motor areas during 30 minutes. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult men and women without history of central nervous system disease and abnormalities
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized transcranial direct current stimulationBased on tDCS stimulation, individualized stimulation during 30 minutes with sitting position. | Device | Individualized stimulation group |
| Conventional transcranial direct current stimulationConventional tDCS stimulation during 30 minutes with sitting position. | Device | Conventional stimulation group |
Primary outcome
Changes in cortical activation
Time frame: 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.
4 secondary outcomes
10 meter walk test (10MWT)
Time frame: Before stimulation (baseline); After strimulation during 30 min
Timed Up and Go test (TUG)
Time frame: Before stimulation (baseline); After strimulation during 30 min
Gait analysis using surface electromyograph
Time frame: Before stimulation (baseline); After strimulation during 30 min
Gait analysis using motion analysis system
Time frame: Before stimulation (baseline); After strimulation during 30 min
Results and safety
The study was stopped early (reason given: The study was terminated due to difficulty in recruiting subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-Hee Kim, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized transcranial direct current stimulation and Conventional transcranial direct current stimulation in people with Healthy Adults and Healthy Aging, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to difficulty in recruiting subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cortical activation (time frame: Change from baseline (before stimulation) after stimulation during 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.