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

Northwell Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Upper Extremity Paralysis; Stroke; Spasticity as Sequela of Stroke; Cerebrovascular Accident (CVA); Muscle Spasticity; Hemiparesis

Treatments: Device: sham Doublestim; Device: anodal Doublestim

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03080454

15-110

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Scale score between 1-3 points for wrist flexor and extensor muscles
4. A minimum of 15 degrees wrist passive range of motion (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 central nervous system (CNS)-active medications

4. Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications

5. Botox or phenol 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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26 participants in 2 patient groups, including a placebo group

Sham Doublestim

Placebo Comparator group

Description:

Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition.

Treatment:

Device: sham Doublestim

Anodal Doublestim

Active Comparator group

Description:

Participants first received 5 daily, consecutive 20 min sessions of sham Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). After a washout period of 1 week, they then received 5 daily, consecutive 20 min sessions of anodal Doublestim (trans-spinal direct current stimulation + peripheral direct current stimulation). For all participants, the sham condition preceded the anodal Doublestim condition.

Treatment:

Device: anodal Doublestim