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Transcutaneous Spinal and Peripheral Stimulation and Wrist Robotic Therapy for Patients With Spastic Stroke

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ClinicalTrials.gov Identifier: NCT04113525
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Bruce Volpe, Northwell Health

Brief Summary:
The purpose of this study is to investigate if two courses of five consecutive sessions of noninvasive spinal stimulation paired with peripheral nerve stimulation at the forearm provided by an investigational device (Doublestim™/ MyoRegulator™ System - PathMaker Neurosystems Inc.) are able to improve wrist stiffness and motor function, when combined with intensive robotic wrist training program in participants with chronic spastic hemiparesis after stroke.

Condition or disease Intervention/treatment Phase
Spasticity as Sequela of Stroke Stroke Stroke Sequelae Hemiplegia, Spastic Hemiparesis Upper Limb Hypertonia CVA Device: MyoRegulator™ System Not Applicable

Detailed Description:

Stroke is the fifth leading cause of death and the leading cause of serious long-term disability in the U.S. Post-stroke impairment often presents as weakness of the upper and lower limbs and spasticity (muscle and joint stiffness and hyperactivity). This condition impacts motor recovery and renders the individual dependent for most activities of daily living. Even with aggressive standard rehabilitation, 65 percent of patients cannot incorporate their affected hand in functional activities six months after stroke. Investigators have previously demonstrated that robotic therapy provides significant benefits to upper limb motor recovery after stroke. The treatment has been acknowledged by the American Heart Association as an effective form of stroke rehabilitation.

Neuromodulation techniques such as noninvasive brain, nerve and spinal direct current stimulation have been proposed as promising safe tools for augmenting motor learning and function after brain injury. Ahmed (2014) demonstrated in a pre-clinical mouse model that the use of combined trans-spinal and peripheral direct current stimulation (tsDCS + pDCS) can modulate muscle tone and potentially improve motor function. Preliminary clinical trial of safety and feasibility (Paget-blanc et al. 2019) suggests that five sessions of transcutaneous spinal direct current stimulation paired with transcutaneous peripheral direct current stimulation (Doublestim™/ MyoRegulator™ System - PathMaker Neurosystems Inc.) temporarily reduce spasticity features such as catch response to slow and fast joint stretch and overall stiffness of the affected extremity with optimal reductions in spasticity occurring 2-3 weeks post stimulation intervention. Unexpectedly, participants also experienced significant improvements in motor function, suggestive that tsDCS+ pDCS may provide a therapeutic window to further augment motor outcomes with robotic wrist training.

The investigators propose a study to evaluate whether two doses of five consecutive days of paired spinal and peripheral noninvasive stimulation combined with six weeks of intensive (three times a week) robotic therapy will significantly alter the clinical and objective measures of spasticity and motor function of the wrist in participants with upper extremity spasticity after stroke.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Treatment With the Doublestim™ Neuromodulation System Incorporating Transcutaneous Spinal Direct Current Stimulation Paired With Robotic Therapy in Patients With Wrist Spasticity After Stroke
Actual Study Start Date : September 24, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Active Stimulation + Robotic Wrist Therapy
Two courses of five consecutive days of 20 minute trans-spinal and trans-peripheral nerve active stimulation (total of 10 sessions) combined with a six-week intensive wrist robotic training program.
Device: MyoRegulator™ System
Paired transcutaneous spinal and peripheral nerve stimulation
Other Name: Doublestim™

Sham Comparator: Sham Stimulation + Robotic Wrist Therapy
Two courses of five consecutive days of 20 minute trans-spinal and trans-peripheral nerve sham stimulation (total of 10 sessions) combined with a six-week intensive wrist robotic training program.
Device: MyoRegulator™ System
Paired transcutaneous spinal and peripheral nerve stimulation
Other Name: Doublestim™




Primary Outcome Measures :
  1. Instrumental assessment of change in wrist muscle tone [ Time Frame: Change from baseline (Admission) at discharge (D-A) and at Four week Follow-up (FU-A) ]
    As primary outcome measure, the team will investigate whether Doublestim™ intervention paired with robotic therapy significantly changes the catch response during wrist extension as recorded by a biomechanical force transducer.


Secondary Outcome Measures :
  1. Changes in upper extremity Fugl-Meyer assessment [ Time Frame: Change from baseline (Admission) at discharge (D-A) and at Four week Follow-up (FU-A) ]
    As secondary outcome measure, the team will test whether active Doublestim™ stimulation (10 sessions) paired with intensive robotic intervention (18 sessions) significantly improves wrist motor function as compared to sham stimulation paired with intensity-matched robotics.



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
Criteria

Inclusion Criteria:

  • ≥ 18 years of age
  • First and only 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 (per interview with PI or study investigators)
  • Fugl-Meyer assessment (minimum score of 12 out of 66 - not completely plegic in the muscles of affected wrist)
  • A Modified Ashworth score between 1-3 points for wrist flexors and extensors
  • A minimum of 15 degrees wrist passive ROM for wrist flexion and extension from wrist neutral position
  • Body fat range of 15-25mm for females/10-20mm for males of adipose tissue at the cervical neck level and a body fat range of 10-40mm for females/5-35mm for males of adipose tissue at the suprailiac crest, as determined by a body fat caliper

Exclusion Criteria:

  • Botox or phenol alcohol treatment of the upper extremity within 3 months of stimulation intervention
  • Fixed contracture or complete flaccid paralysis of the affected wrist
  • Introduction of any new rehabilitation interventions during study
  • Pregnant or plan on becoming pregnant or breastfeeding during the study period as determined by self-report
  • Focal brainstem or thalamic infarcts
  • Prior surgical treatments for spasticity of the upper limb
  • Ongoing use of CNS-active medications for spasticity (enrollment to be determined by PI review)
  • History of spinal cord injury or weakness
  • Chronic pain, defined by a report of a "5" or greater on the Wong-Baker Pain Scale
  • 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; Loop recorders will be reviewed on a case by case basis by PI and the treating Cardiologist to make a determination
    • Highly conductive metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation); this will be reviewed on a case by case basis for PI to make a determination
  • 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 ClinicalTrials.gov identifier (NCT number): NCT04113525


Contacts
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Contact: Johanna Chang, MS, CCC-SLP 516-562-3646 jchang14@northwell.edu
Contact: Bruce T Volpe, MD 516-562-3384 bvolpe1@northwell.edu

Locations
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United States, New York
The Feinstein Institutes For Medical Research - Northwell Health Recruiting
Manhasset, New York, United States, 11030
Contact: Johanna Chang, MS, CCC-SLP    516-562-3646    jchang14@northwell.edu   
Contact: Bruce T Volpe, MD    516-562-3384    bvolpe1@northwell.edu   
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Bruce T Volpe, MD The Feinstein Institutes For Medical Research - Northwell Health
Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Bruce Volpe, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT04113525    
Other Study ID Numbers: 19-0063
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Bruce Volpe, Northwell Health:
Stroke Rehabilitation
Neuromodulation
Transcutaneous Spinal Direct Current Stimulation
Robotic Therapy
Transcutaneous Peripheral Direct Current Stimulation
Spasticity
Hemiparesis
Additional relevant MeSH terms:
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Muscle Spasticity
Stroke
Hemiplegia
Paresis
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
Paralysis