Neurological Rehabilitation, Recovery of Function, Stroke, Transcranial Direct Current Stimulation
Conditions
Brief 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). 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.
Interventions
DEVICEtDCS
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.
Sponsors
the Ministry of Trade, Industry & Energy(MOTIE, Korea), Ybrain (Korea)
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
An investigator who applies the tDCS to the participants will not be masked. However, other investigators including outcome assessors and participants will be masked. The other care providers in our department (e.g. other physio- or occupational therapists) will be masked.
Intervention model description
Randomized, double-blind, sham-controlled, parallel group design
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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,
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment (FMA) scores of the upper extremity | Change from Baseline FMA at 2 weeks | range: 0 (worst) -66 (best) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brunnstrom stage (B-stage) of arm | Change from baseline B-stage at 2 weeks | range: 1(worst) -6 (best) |
| Box and Block Test (BBT) | Change from baseline BBT at 2 weeks | maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds, more numbers mean better function |
| Modified Ashworth Scale | 2 weeks after baseline | to measure the spasticity: 6 grades: 0 (no spasticity), 1, 1+, 2, 3, 4 (severe spasticity) |
| Korean version of modified Barthel Index (K-MBI) | Change from baseline K-MBI at 2 weeks | range: 0 (worst) -100 (best) |
| Laterality Index | 2 weeks after baseline | Ratio of the cortical activation between the contra- and ipsilesional motor area recorded by the electroencephalography |
| Fugl-Meyer Assessment (FMA) scores of the upper extremity | Change from Baseline FMA at 6 weeks | range: 0 (worst) -66 (best) |
| Manual muscle power test | 2 weeks after baseline | 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). |
Countries
South Korea
Contacts
Primary ContactWon-Seok Kim, MD, PhD
Backup ContactJihong Park, MD
Outcome results
None listed