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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
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.
Seoul National University Bundang Hospital
Seongnam-si, Please Select, South Korea
RECRUITINGFugl-Meyer Assessment (FMA) scores of the upper extremity
range: 0 (worst) -66 (best)
Time frame: Change from Baseline FMA at 2 weeks
Korean version of modified Barthel Index (K-MBI)
range: 0 (worst) -100 (best)
Time frame: Change from baseline K-MBI at 2 weeks
Korean version of modified Barthel Index (K-MBI)
range: 0 (worst) -100 (best)
Time frame: Change from baseline K-MBI at 6 weeks
Brunnstrom stage (B-stage) of arm
range: 1(worst) -6 (best)
Time frame: Change from baseline B-stage at 2 weeks
Brunnstrom stage (B-stage) of arm
range: 1(worst) -6 (best)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 2 weeks after baseline
Modified Ashworth Scale
to measure the spasticity: 6 grades: 0 (no spasticity), 1, 1+, 2, 3, 4 (severe spasticity)
Time frame: 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).
Time frame: 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).
Time frame: 6 weeks after baseline
Laterality Index
Ratio of the cortical activation between the contra- and ipsilesional motor area recorded by the electroencephalography
Time frame: 2 weeks after baseline
Laterality Index
Ratio of the cortical activation between the contra- and ipsilesional motor area recorded by the electroencephalography
Time frame: 6 weeks after baseline
Fugl-Meyer Assessment (FMA) scores of the upper extremity
range: 0 (worst) -66 (best)
Time frame: Change from Baseline FMA at 6 weeks
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