The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Stroke, Cerebrovascular Accident (CVA), Hemiparesis, Spasticity as Sequela of Stroke, Muscle Spasticity, Upper Extremity Paralysis

Intervention / Treatment
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* Device: sham Doublestim
* Device: anodal Doublestim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First single focal unilateral hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior Cognitive function sufficient to understand the experiments and follow instructions A Modified Ashworth Scale score between 1-3 points for wrist flexor and extensor muscles A minimum of 15 degrees wrist passive range of motion (ROM) for wrist flexion and extension from wrist neutral position Exclusion Criteria: Focal brainstem or thalamic infarcts Prior surgical treatments for spasticity of the upper limb Ongoing use of central nervous system (CNS)-active medications Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications Botox or phenol alcohol treatment within 12 weeks of enrollment Pregnancy in women, as determined by self-report History of spinal cord injury or weakness Chronic pain Peripheral neuropathy including insulin dependent diabetes as determined by case history Presence of additional potential tsDCS risk factors: Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed recent scar tissue, broken skin, etc.) Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system Highly conductive metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation) Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All participants received both stimulation conditions (sham Doublestim and anodal Doublestim), separated by a 1-week washout period.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sham Doublestim<br>Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition. | Device: sham Doublestim<br>* PathMaker MyoRegulator device<br>* Other names: sham trans-spinal direct current stimulation + peripheral direct current stimulation (tsDCS + pDCS);|
| Active Comparator: Anodal Doublestim<br>Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition. | Device: anodal Doublestim<br>* PathMaker MyoRegulator device<br>* Other names: anodal trans-spinal direct current stimulation + peripheral direct current stimulation (tsDCS + pDCS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | baseline, final session at day 5, 1 week FU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | baseline, final session at day 5, 1 week FU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, CVA, Spasticity, hemiparesis, rehabilitation, trans-spinal direct current stimulation (tsDCS), non-invasive stimulation