Feinstein Institute for Medical Research
Manhasset, New York, 11030, United States
NCT Number: NCT03080454
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Manhasset, New York, 11030, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PathMaker MyoRegulator device
Other names: sham trans-spinal direct current stimulation + peripheral direct current stimulation (tsDCS + pDCS)
PathMaker MyoRegulator device
Other names: anodal trans-spinal direct current stimulation + peripheral direct current stimulation (tsDCS + pDCS)
Time frame: baseline, final session at day 5, 1 week FU
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
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).
Northwell Health
Other
The Effect of Treatment With the PathMaker Myoregulator Neuromodulation System Incorporating Trans-spinal Direct Current Stimulation (tsDCS) in Patients With Severe Hand Spasticity After Stroke
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