The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Stroke, Cerebrovascular Accident (CVA), Hemiparesis, Spasticity as Sequela of Stroke, Muscle Spasticity, Upper Extremity Paralysis
In brief
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.
Key facts
- Study ID
- NCT03080454
- Run by
- Northwell Health
- People needed
- 26
- Starts
- 2016-09-01
- Expected to finish
- 2018-03-01
- Last updated by the study team
- 2021-04-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Feinstein Institute for Medical Research — Manhasset, New York, United States
Full record on ClinicalTrials.gov
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