The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke
Status: | Active, not recruiting |
---|---|
Conditions: | Neurology, Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/23/2018 |
Start Date: | September 2016 |
End Date: | January 2019 |
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
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.
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.
Inclusion Criteria:
1. First single focal unilateral hemisphere lesion with diagnosis verified by brain
imaging (MRI or CT scans) that occurred at least 6 months prior
2. Cognitive function sufficient to understand the experiments and follow instructions
3. A Modified Ashworth score between 1-3 points for wrist flexors and extensor muscles
4. A minimum of 15 degrees wrist passive ROM for wrist flexion and extension from wrist
neutral position
Exclusion Criteria:
1. Focal brainstem or thalamic infarcts
2. Prior surgical treatments for spasticity of the upper limb
3. Ongoing use of CNS-active medications
4. Ongoing use of psychoactive medications, such as stimulants, antidepressants, and
anti-psychotic medications
5. Botox or phenal alcohol treatment within 12 weeks of enrollment
6. Pregnancy in women, as determined by self-report
7. History of spinal cord injury or weakness
8. Chronic pain
9. Peripheral neuropathy including insulin dependent diabetes as determined by case
history
10. 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
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