Phase 2
N=26
The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke
Stroke · Cerebrovascular Accident (CVA) · Hemiparesis · Spasticity as Sequela of Stroke · Muscle Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT03080454 ↗Enrolled (actual)
26
Serious AEs
5.4%
Results posted
Sep 2019
Primary outcome: Primary: Mean Percent Change From Baseline in Area Under the Curve for Objectively Measured Spastic Catch Response of the Wrist Flexors at Fast Speed — 13.678; -8.783; 15.927; -16.333 percent change — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sham Doublestim (Device); anodal Doublestim (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change From Baseline in Area Under the Curve for Objectively Measured Spastic Catch Response of the Wrist Flexors at Fast Speed |
13.678; -8.783; 15.927; -16.333 | 0.004 sig |
| SECONDARY Mean Modified Tardieu Scale (MTS) Score |
23.375; 21.625; 23.125; 21.975 | 0.003 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03080454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.