CompletedPhase 1/2

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

United States26 participantsStarted 2016-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Mean Percent Change From Baseline in Area Under the Curve for Objectively Measured Spastic Catch Response of the Wrist Flexors at Fast Speed

Timeframe: baseline, final session at day 5, 1 week FU

Trial details

NCT IDNCT03080454

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03

Results submitted2019-02-22

View on ClinicalTrials.gov More Stroke trials