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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03080454
Recruitment Status : Active, not recruiting
First Posted : March 15, 2017
Last Update Posted : August 21, 2018
PathMaker Neurosystems Inc
Dr. Zaghloul Ahmed
Information provided by (Responsible Party):
Bruce Volpe, Northwell Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke CVA Hemiparesis Spasticity as Sequela of Stroke Muscle Spasticity Upper Extremity Paralysis Device: Pathmaker MyoRegulator neuromodulation system Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Doublestim anodal stimulation Device: Pathmaker MyoRegulator neuromodulation system
Sham Comparator: Doublestim sham stimulation Device: Pathmaker MyoRegulator neuromodulation system

Primary Outcome Measures :
  1. Instrumental assessment of muscle tone [ Time Frame: Conditions 1 & 2: change from baseline at day 3 and 5 of stimulation, and at follow-up weeks 1-4 ]
    objective assessment of passive muscle resistance with a force transducer

Secondary Outcome Measures :
  1. Tardieu Scale [ Time Frame: Conditions 1 & 2: change from baseline at day 3 and 5 of stimulation, and at follow-up weeks 1-4 ]
    Clinical assessment of spasticity of the upper extremity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03080454

United States, New York
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
PathMaker Neurosystems Inc
Dr. Zaghloul Ahmed


Responsible Party: Bruce Volpe, Principal Investigator, Northwell Health Identifier: NCT03080454     History of Changes
Other Study ID Numbers: 15-110
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bruce Volpe, Northwell Health:
non-invasive stimulation

Additional relevant MeSH terms:
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms