The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke
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The purpose of this study is to evaluate if 5 consecutive sessions of PathMaker 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.
Condition or disease
StrokeCVAHemiparesisSpasticity as Sequela of StrokeMuscle SpasticityUpper Extremity Paralysis
Device: Pathmaker MyoRegulator neuromodulation system
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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 score between 1-3 points for wrist flexors and extensor muscles
A minimum of 15 degrees wrist passive ROM for wrist flexion and extension from wrist neutral position
Focal brainstem or thalamic infarcts
Prior surgical treatments for spasticity of the upper limb
Ongoing use of CNS-active medications
Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
Botox or phenal alcohol treatment within 12 weeks of enrollment
Pregnancy in women, as determined by self-report
History of spinal cord injury or weakness
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