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OpenTrials
Completed

NCT Number: NCT03080454

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sham Doublestim

Device

PathMaker MyoRegulator device

Other names: sham trans-spinal direct current stimulation + peripheral direct current stimulation (tsDCS + pDCS)

anodal Doublestim

Device

PathMaker MyoRegulator device

Other names: anodal trans-spinal direct current stimulation + peripheral direct current stimulation (tsDCS + pDCS)

Primary outcomes

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

    Time frame: baseline, final session at day 5, 1 week FU

    Subjects' wrists were passively extended at fast speed by a stepper motor to induce a spastic catch response, and its resistance torque was calculated in Newton meters (Nm). Mean percent change from baseline in the area under the curve for the resistance torque were compared across two timepoints (final session at day 5 and 1 week follow-up) in two conditions (sham vs. anodal Doublestim)

Secondary outcomes

  1. Mean Modified Tardieu Scale (MTS) Score

    Time frame: baseline, final session at day 5, 1 week FU

    The Modified Tardieu Scale (MTS) quantifies muscle spasticity for each joint at slow and fast velocities on a 0-5 point scale. MTS scores at fast velocity were summed across 11 joints of the upper extremity (for a total of 0-55 points), with lower scores indicating improved spasticity. Mean summed MTS scores (out of 55 total points) were compared across two timepoints (final session at day 5 and 1 week FU) in two conditions (sham vs. anodal Doublestim).

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Dr. Zaghloul Ahmed
  • PathMaker Neurosystems Inc.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2017
Registry last updated
Apr 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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