The purpose of this study is to evaluate if 5 consecutive sessions of PathMaker anodal DoubleStim treatment, which combines non-invasive stimulation of the spinal cord (tsDCS- trans-spinal direct current stimulation) and of the median nerve at the peripheral wrist (pDCS-- peripheral direct current stimulation), can significantly reduce spasticity of the wrist and hand after stroke.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
26
PathMaker MyoRegulator device
PathMaker MyoRegulator device
Feinstein Institute for Medical Research
Manhasset, New York, United States
Mean Percent Change From Baseline in Area Under the Curve for Objectively Measured Spastic Catch Response of the Wrist Flexors at Fast Speed
Subjects' wrists were passively extended at fast speed by a stepper motor to induce a spastic catch response, and its resistance torque was calculated in Newton meters (Nm). Mean percent change from baseline in the area under the curve for the resistance torque were compared across two timepoints (final session at day 5 and 1 week follow-up) in two conditions (sham vs. anodal Doublestim)
Time frame: baseline, final session at day 5, 1 week FU
Mean Modified Tardieu Scale (MTS) Score
The Modified Tardieu Scale (MTS) quantifies muscle spasticity for each joint at slow and fast velocities on a 0-5 point scale. MTS scores at fast velocity were summed across 11 joints of the upper extremity (for a total of 0-55 points), with lower scores indicating improved spasticity. Mean summed MTS scores (out of 55 total points) were compared across two timepoints (final session at day 5 and 1 week FU) in two conditions (sham vs. anodal Doublestim).
Time frame: baseline, final session at day 5, 1 week FU
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