StrokeNCT03460886
Most Effective Stimulation Site in Transcranial Direct Current Stimulation for Gait Recovery After Stoke
A study testing Ipsilesional stimulation, Contralesional stimulation and Walking on treadmill in people with Stroke and Gait Disorders, Neurologic, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The aim of this study is to investigate the most effective stimulation site in transcranial direct current stimulation for gait recovery after stroke. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke, Gait Disorders, Neurologic
- What is being tested?
- Ipsilesional stimulation, Contralesional stimulation and Walking on treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2018to 30 May 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke patients with 6 months after onset.
- Functional ambulation category ≥ 3
Who cannot join
- patients who needs assist in surface level walking
- patients with mini mental status exam score under 9
- patients with implantable electronic device
- metal device inside skull
- history of epilepsy
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the most effective stimulation site in transcranial direct current stimulation for gait recovery after stroke. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) bihemispheric stimulation - anodal stimulation on both ipsilesional and contralesional leg area of primary motor cortex and supplementary motor area. 2) ipsilesional stimulation - anodal stimulation on ipsilesional leg area of primary motor cortex and supplementary motor area. 3) contralesional stimulation - anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area. 4) sham stimulation. Subjects will walk on treadmill for 10 minutes during transcranial direct current stimulation. Motor evoked potential and functional evaluations will be done before and after stimulation to measure the changes.
- Conditions
- Stroke, Gait Disorders, Neurologic
- Being tested
- Ipsilesional stimulation, Contralesional stimulation, Walking on treadmill
- Keywords
- transcranial direct current stimulation
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipsilesional stimulationDevice
anodal stimulation on Ipsilesional leg area of primary motor cortex and supplementary motor area for 30 minutes
Contralesional stimulationDevice
anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area for 30 minutes
Walking on treadmillOther
walking on treadmill for 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Bihemispheric stimulation | Experimental | 1. Anodal stimulation on ipsilesional leg motor primary cortex and supplementary motor area
2. Anodal stimulation on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation. Receives: Device: Ipsilesional stimulation; Device: Contralesional stimulation; Other: Walking on treadmill |
| Ipsilesional stimulation | Experimental | 1. Anodal stimulation on ipsilesional leg motor primary cortex and supplementary motor area
2. Sham on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation. Receives: Device: Ipsilesional stimulation; Other: Walking on treadmill |
| Contralesional stimulation | Experimental | 1. Sham stimulation on ipsilesional leg motor primary cortex and supplementary motor area
2. Anodal stimulation on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation. Receives: Device: Contralesional stimulation; Other: Walking on treadmill |
| Sham | Active comparator | 1. Sham stimulation on ipsilesional leg motor primary cortex and supplementary motor area
2. Sham stimulation on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation. Receives: Other: Walking on treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in motor evoked potential
measure the motor threshold and amplitude of motor evoked potential in tibialis anterior muscle.
Measured: before and after intervention (approximately 30 minutes)
Secondary outcomes (6)
Changes in motricity index
measures motor function
Measured: before and after intervention (approximately 30 minutes)
Changes in Fugl Meyer Assessment
Fugl Meyer Assessment is a measurement of motor function.
Measured: before and after intervention (approximately 30 minutes)
Changes in 10 meter walking test
measures gait speed
Measured: before and after intervention (approximately 30 minutes)
Timed up and go test
measures gait capacity and balance
Measured: before and after intervention (approximately 30 minutes)
Functional ambulatory category
measure gait ability. 0 is impossible to gait and 6 is normal.
Measured: before and after intervention (approximately 30 minutes)
Modified ashworth scale
measures spasticity with scale from 0 to 3. 0 is no increase in muscle tone. 3 is considerable increase in muscle tone, passive movement difficult.
Measured: before and after intervention (approximately 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Feb 2018
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460886
- Sponsor's protocol ID
- 2017-11-080
- Status last verified
- Sep 2019
- First submitted
- 22 Jan 2018
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Most Effective Stimulation Site in Transcranial Direct Current Stimulation for Gait Recovery After Stoke
- ClinicalTrials.gov ID
- NCT03460886
- Acronym / sponsor ID
- 2017-11-080
- Conditions
- Stroke, Gait Disorders, Neurologic
- Keywords
- transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 9 Mar 2018 (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 aim of this study is to investigate the most effective stimulation site in transcranial direct current stimulation for gait recovery after stroke. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) bihemispheric stimulation - anodal stimulation on both ipsilesional and contralesional leg area of primary motor cortex and supplementary motor area. 2) ipsilesional stimulation - anodal stimulation on ipsilesional leg area of primary motor cortex and supplementary motor area. 3) contralesional stimulation - anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area. 4) sham stimulation. Subjects will walk on treadmill for 10 minutes during transcranial direct current stimulation. Motor evoked potential and functional evaluations will be done before and after stimulation to measure the changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bihemispheric stimulation | Experimental | Device: Ipsilesional stimulation, Device: Contralesional stimulation, Other: Walking on treadmill1. Anodal stimulation on ipsilesional leg motor primary cortex and supplementary motor area 2. Anodal stimulation on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation. |
| Ipsilesional stimulation | Experimental | Device: Ipsilesional stimulation, Other: Walking on treadmill1. Anodal stimulation on ipsilesional leg motor primary cortex and supplementary motor area 2. Sham on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation. |
| Contralesional stimulation | Experimental | Device: Contralesional stimulation, Other: Walking on treadmill1. Sham stimulation on ipsilesional leg motor primary cortex and supplementary motor area 2. Anodal stimulation on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation. |
| Sham | Active comparator | Other: Walking on treadmill1. Sham stimulation on ipsilesional leg motor primary cortex and supplementary motor area 2. Sham stimulation on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic stroke patients with 6 months after onset.
- Functional ambulation category ≥ 3
Key exclusion criteria (6 listed)
- patients who needs assist in surface level walking
- patients with mini mental status exam score under 9
- patients with implantable electronic device
- metal device inside skull
- history of epilepsy
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 |
|---|---|---|
| Ipsilesional stimulationanodal stimulation on Ipsilesional leg area of primary motor cortex and supplementary motor area for 30 minutes | Device | Bihemispheric stimulation, Ipsilesional stimulation |
| Contralesional stimulationanodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area for 30 minutes | Device | Bihemispheric stimulation, Contralesional stimulation |
| Walking on treadmillwalking on treadmill for 10 minutes | Other | Bihemispheric stimulation, Contralesional stimulation, Ipsilesional stimulation, Sham |
Primary outcome
Changes in motor evoked potential
Time frame: before and after intervention (approximately 30 minutes)
measure the motor threshold and amplitude of motor evoked potential in tibialis anterior muscle.
6 secondary outcomes
Changes in motricity index
Time frame: before and after intervention (approximately 30 minutes)
Changes in Fugl Meyer Assessment
Time frame: before and after intervention (approximately 30 minutes)
Changes in 10 meter walking test
Time frame: before and after intervention (approximately 30 minutes)
Timed up and go test
Time frame: before and after intervention (approximately 30 minutes)
Functional ambulatory category
Time frame: before and after intervention (approximately 30 minutes)
Modified ashworth scale
Time frame: before and after intervention (approximately 30 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ipsilesional stimulation, Contralesional stimulation and Walking on treadmill in people with Stroke and Gait Disorders, Neurologic, 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 2 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: finished, as of the sponsor's last update on 20 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 motor evoked potential (time frame: before and after intervention (approximately 30 minutes)). 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 20 Sep 2019.