StrokeNCT03635008
Anodal Transcranial Direct Current Stimulation Over the Contralesional Hemisphere on Motor Recovery in Subacute Stroke Patients
A study testing tDCS in people with Stroke and Transcranial Direct Current Stimulation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Upper limb recovery is not predicted by the initial severity of paralysis and the parameters reflecting the integrity of the corticospinal tract (e.g. motor evoked potential, fractional anisotropy in diffusion tensor imaging). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Transcranial Direct Current Stimulation, Recovery of Function
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Oct 2018to 15 May 2024
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-85 years old
- Ischemic or Hemorrhagic stroke confirmed by the MRI or CT
- First-ever stroke
- < 3 months after stroke
- Unilateral upper limb weakness due to the stroke and meets the following all conditions: (1)Shoulder Abduction Finger Extension (SAFE) score (range 0-10) revealing the motor paralysis is below 8 (lower score mean worse function)), (2)Fugl Meyer Assessment score in the affected upper extremity is 25 or under 25. (3)No response in the motor evoked potential recorded on the affected extensor carpi radialis muscle,
Who cannot join
- recurrent stroke
- history of the other brain injury (e.g. traumatic brain injury)
- poor cognitive function (score of korean version of mini-mental state exam is 15 or below 15).
- Poor cooperation due to delirium or problems in the consciousness
- Uncontrolled or unstable medical conditions.
- Pregnant
Show all 10Show fewer
- Scalp problems which interfere with the tDCS application
- Robotic arm training can not be applied due to the unstable sitting posture or head control, or arm pain.
- Metals in the head (e.g. clip, coil)
- Cardiac pacemaker or cochlear implants
Trial locations and contacts
1 site in 1 country.
Jihong Park, MD contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Please Select, 13620
Won-Seok Kim, MD
About this study
Official title: Effects of Anodal Transcranial Direct Current Stimulation Over the Contralesional Hemisphere on Motor Recovery in Subacute Stroke Patients With Severe Upper Extremity Hemiparesis: Study Protocol for a Randomized Controlled Trial
Upper limb recovery is not predicted by the initial severity of paralysis and the parameters reflecting the integrity of the corticospinal tract (e.g. motor evoked potential, fractional anisotropy in diffusion tensor imaging). Although the inhibition of the contralesional hemisphere is known to be beneficial for the upper limb recovery after stroke in previous studies, this is not proven in the severely paralyzed upper limb. And the studies using the noninvasive stimulation in subacute stroke is lack. In addition, the role of contralesional (unaffected) hemisphere is known to be playing the important role in severe stroke.
In this randomized, double-blind, sham-controlled studies, the patients with subacute stroke (<3 months after stroke onset), severe paralysis of the upper limb with poor prognosis (poor motor score and no response of motor evoked potential recorded in the extensor carpi radialis muscle) will be recruited. Interventional group will receive the 25 mins of anodal transcranial direct current stimulation (tDCS) over the contralesional premotor area plus 25 mins of robotic arm training per session for 10 sessions in 2 weeks. Control group will receive the same treatment except for sham tDCS instead of anodal tDCS over the contralesional premotor area. Functional outcome will be measured before and after the intervention (baseline, immediately after the intervention and 1 month after the intervention). Cortical activation pattern will be measured by the electroencephalography (EEG) at baseline and immediately after the intervention.
- Conditions
- Stroke, Transcranial Direct Current Stimulation, Recovery of Function, Neurological Rehabilitation
- Being tested
- tDCS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Regard to the anodal tDCS, the anode will be placed over the contralesional premotor area (2.5 cm anterior to the C3 or C4 in 10-20 EEG system) and cathode will be placed over the contralateral supraorbital area. The stimulation intensity will be 2mA. For the sham tDCS the stimulation will be applied for just first 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Experimental | This group will receive the 25 mins of the tDCS (Yrain, Korea) over the contralesional premotor area simultaneously with 25 mins of the robotic arm training using Armeo Power (Hocoma, Switzerland), per day. Additional 30 mins of occupational therapy focusing on the arm motor recovery will be provided per day. These interventions will be provided for 10 weekdays. Other conventional rehabilitation (e.g. gait training, speech therapy) will be permitted.
Regard to the anodal tDCS, the anode will be placed over the contralesional premotor area (2.5 cm anterior to the C3 or C4 in 10-20 EEG system) and cathode will be placed over the contralateral supraorbital area. The stimulation intensity will be 2mA. Receives: Device: tDCS |
| sham tDCS | Placebo comparator | This group will receive the 25 mins of the tDCS (Yrain, Korea) over the contralesional premotor area simultaneously with 25 mins of the robotic arm training using Armeo Power (Hocoma, Switzerland), per day. Additional 30 mins of occupational therapy focusing on the arm motor recovery will be provided per day. These interventions will be provided for 10 weekdays. Other conventional rehabilitation (e.g. gait training, speech therapy) will be permitted.
Regard to the sham tDCS, the anode will be placed over the contralesional premotor area (2.5 cm anterior to the C3 or C4 in 10-20 EEG system) and cathode will be placed over the contralateral supraorbital area. The stimulation intensity will be started but the intensity will decrease and stop in 30 seconds. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA) scores of the upper extremity
range: 0 (worst) -66 (best)
Measured: Change from Baseline FMA at 2 weeks
Secondary outcomes (13)
Korean version of modified Barthel Index (K-MBI)
range: 0 (worst) -100 (best)
Measured: Change from baseline K-MBI at 2 weeks
Korean version of modified Barthel Index (K-MBI)
range: 0 (worst) -100 (best)
Measured: Change from baseline K-MBI at 6 weeks
Brunnstrom stage (B-stage) of arm
range: 1(worst) -6 (best)
Measured: Change from baseline B-stage at 2 weeks
Brunnstrom stage (B-stage) of arm
range: 1(worst) -6 (best)
Measured: Change from baseline B-stage at 6 weeks
Box and Block Test (BBT)
maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds, more numbers mean better function
Measured: Change from baseline BBT at 2 weeks
Box and Block Test (BBT)
maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds, more numbers mean better function
Measured: Change from baseline BBT at 6 weeks
Modified Ashworth Scale
to measure the spasticity: 6 grades: 0 (no spasticity), 1, 1+, 2, 3, 4 (severe spasticity)
Measured: 2 weeks after baseline
Modified Ashworth Scale
to measure the spasticity: 6 grades: 0 (no spasticity), 1, 1+, 2, 3, 4 (severe spasticity)
Measured: 6 weeks after baseline
Manual muscle power test
3 proximal (shoulder abduction, elbow flexion, and extension) and 5 distal (flexion and extension of the hand and fingers, and thumb flexion) muscle groups, 6 grades ranges from 0 (flaccid) to 5 (strongest).
Measured: 2 weeks after baseline
Manual muscle power test
3 proximal (shoulder abduction, elbow flexion, and extension) and 5 distal (flexion and extension of the hand and fingers, and thumb flexion) muscle groups, 6 grades ranges from 0 (flaccid) to 5 (strongest).
Measured: 6 weeks after baseline
Laterality Index
Ratio of the cortical activation between the contra- and ipsilesional motor area recorded by the electroencephalography
Measured: 2 weeks after baseline
Laterality Index
Ratio of the cortical activation between the contra- and ipsilesional motor area recorded by the electroencephalography
Measured: 6 weeks after baseline
Fugl-Meyer Assessment (FMA) scores of the upper extremity
range: 0 (worst) -66 (best)
Measured: Change from Baseline FMA at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start15 Oct 2018
- Primary completion15 Mar 2024 (estimated)
- Study completion15 May 2024 (estimated)
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 Seoul National University HospitalThe 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
- Parallel groups
- Model description
- Randomized, double-blind, sham-controlled, parallel group design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- the Ministry of Trade, Industry & Energy(MOTIE, Korea), Ybrain (Korea)
- Responsible party
- Principal investigator, Won-Seok Kim, Seoul National University Bundang Hospital
- Investigators
- Won-Seok Kim, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635008
- Sponsor's protocol ID
- B-1805/468-002
- Status last verified
- May 2022
- First submitted
- 14 Jul 2018
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are not planning to share the individual data publicly. However, if other researchers interested in our project, they can contact PI by email and we can discuss further for the sharing. If data sharing is decided after the discussion with other researchers, we will consider sharing after the review of the appropriateness by our institutional review board.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anodal Transcranial Direct Current Stimulation Over the Contralesional Hemisphere on Motor Recovery in Subacute Stroke Patients With Severe Upper Extremity Hemiparesis: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03635008
- Acronym / sponsor ID
- B-1805/468-002
- Conditions
- Stroke, Transcranial Direct Current Stimulation, Recovery of Function, Neurological Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- the Ministry of Trade, Industry & Energy(MOTIE, Korea), Ybrain (Korea)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 17 Aug 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.
Upper limb recovery is not predicted by the initial severity of paralysis and the parameters reflecting the integrity of the corticospinal tract (e.g. motor evoked potential, fractional anisotropy in diffusion tensor imaging). Although the inhibition of the contralesional hemisphere is known to be beneficial for the upper limb recovery after stroke in previous studies, this is not proven in the severely paralyzed upper limb. And the studies using the noninvasive stimulation in subacute stroke is lack. In addition, the role of contralesional (unaffected) hemisphere is known to be playing the important role in severe stroke.
In this randomized, double-blind, sham-controlled studies, the patients with subacute stroke (<3 months after stroke onset), severe paralysis of the upper limb with poor prognosis (poor motor score and no response of motor evoked potential recorded in the extensor carpi radialis muscle) will be recruited. Interventional group will receive the 25 mins of anodal transcranial direct current stimulation (tDCS) over the contralesional premotor area plus 25 mins of robotic arm training per session for 10 sessions in 2 weeks. Control group will receive the same treatment except for sham tDCS instead of anodal tDCS over the contralesional premotor area. Functional outcome will be measured before and after the intervention (baseline, immediately after the intervention and 1 month after the intervention). Cortical activation pattern will be measured by the electroencephalography (EEG) at baseline and immediately after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, sham-controlled, parallel group design
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Experimental | Device: tDCSThis group will receive the 25 mins of the tDCS (Yrain, Korea) over the contralesional premotor area simultaneously with 25 mins of the robotic arm training using Armeo Power (Hocoma, Switzerland), per day. Additional 30 mins of occupational therapy focusing on the arm motor recovery will be provided per day. These interventions will be provided for 10 weekdays. Other conventional rehabilitation (e.g. gait training, speech therapy) will be permitted. Regard to the anodal tDCS, the anode will be placed over the contralesional premotor area (2.5 cm anterior to the C3 or C4 in 10-20 EEG system) and cathode will be placed over the contralateral supraorbital area. The stimulation intensity will be 2mA. |
| sham tDCS | Placebo comparator | Device: tDCSThis group will receive the 25 mins of the tDCS (Yrain, Korea) over the contralesional premotor area simultaneously with 25 mins of the robotic arm training using Armeo Power (Hocoma, Switzerland), per day. Additional 30 mins of occupational therapy focusing on the arm motor recovery will be provided per day. These interventions will be provided for 10 weekdays. Other conventional rehabilitation (e.g. gait training, speech therapy) will be permitted. Regard to the sham tDCS, the anode will be placed over the contralesional premotor area (2.5 cm anterior to the C3 or C4 in 10-20 EEG system) and cathode will be placed over the contralateral supraorbital area. The stimulation intensity will be started but the intensity will decrease and stop in 30 seconds. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-85 years old
- Ischemic or Hemorrhagic stroke confirmed by the MRI or CT
- First-ever stroke
- < 3 months after stroke
- Unilateral upper limb weakness due to the stroke and meets the following all conditions: (1)Shoulder Abduction Finger Extension (SAFE) score (range 0-10) revealing the motor paralysis is below 8 (lower score mean worse function)), (2)Fugl Meyer Assessment score in the affected upper extremity is 25 or under 25. (3)No response in the motor evoked potential recorded on the affected extensor carpi radialis muscle,
Key exclusion criteria (10 listed)
- recurrent stroke
- history of the other brain injury (e.g. traumatic brain injury)
- poor cognitive function (score of korean version of mini-mental state exam is 15 or below 15).
- Poor cooperation due to delirium or problems in the consciousness
- Uncontrolled or unstable medical conditions.
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 |
|---|---|---|
| tDCSRegard to the anodal tDCS, the anode will be placed over the contralesional premotor area (2.5 cm anterior to the C3 or C4 in 10-20 EEG system) and cathode will be placed over the contralateral supraorbital area. The stimulation intensity will be 2mA. For the sham tDCS the stimulation will be applied for just first 30 seconds. | Device | Anodal tDCS, sham tDCS |
Primary outcome
Fugl-Meyer Assessment (FMA) scores of the upper extremity
Time frame: Change from Baseline FMA at 2 weeks
range: 0 (worst) -66 (best)
13 secondary outcomes
Korean version of modified Barthel Index (K-MBI)
Time frame: Change from baseline K-MBI at 2 weeks
Korean version of modified Barthel Index (K-MBI)
Time frame: Change from baseline K-MBI at 6 weeks
Brunnstrom stage (B-stage) of arm
Time frame: Change from baseline B-stage at 2 weeks
Brunnstrom stage (B-stage) of arm
Time frame: Change from baseline B-stage at 6 weeks
Box and Block Test (BBT)
Time frame: Change from baseline BBT at 2 weeks
Box and Block Test (BBT)
Time frame: Change from baseline BBT at 6 weeks
Modified Ashworth Scale
Time frame: 2 weeks after baseline
Modified Ashworth Scale
Time frame: 6 weeks after baseline
Manual muscle power test
Time frame: 2 weeks after baseline
Manual muscle power test
Time frame: 6 weeks after baseline
Laterality Index
Time frame: 2 weeks after baseline
Laterality Index
Time frame: 6 weeks after baseline
Fugl-Meyer Assessment (FMA) scores of the upper extremity
Time frame: Change from Baseline FMA at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: Undecided. We are not planning to share the individual data publicly. However, if other researchers interested in our project, they can contact PI by email and we can discuss further for the sharing. If data sharing is decided after the discussion with other researchers, we will consider sharing after the review of the appropriateness by our institutional review board.
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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.
Jihong Park, MD contact
Won-Seok Kim, MD, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Stroke and Transcranial Direct Current Stimulation, run by Seoul National University Hospital 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 17 May 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Won-Seok Kim, MD, PhD (+82317877735, wondol77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (FMA) scores of the upper extremity (time frame: Change from Baseline FMA at 2 weeks). 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 17 May 2022.