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Restoration of Reaching and Grasping Function in Individuals With Spinal Cord Injury Using MyndMove® Neuromodulation Therapy

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ClinicalTrials.gov Identifier: NCT03439319
Recruitment Status : Not yet recruiting
First Posted : February 20, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
U.S. Army Medical Research Acquisition Activity
United States Department of Defense
Programs for Assessment of Technology in Health Research Institute
McMaster University
Information provided by (Responsible Party):
MyndTec Inc.

Brief Summary:
A two-arm, parallel group, multicentre, single-blind, randomized controlled trial comparing electrical neuromodulation delivered by MyndMove® therapy to intensive upper-limb conventional therapy in the treatment of patients with moderate to severe motor impairment to their arms and hands from an incomplete, sub-acute, traumatic spinal cord injury.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Trauma, Nervous System Device: MyndMove® Other: Conventional Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A two-arm, parallel group, multicentre, single-blind, randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Restoration of Reaching and Grasping Function in Individuals With Spinal Cord Injury Using MyndMove® Neuromodulation Therapy
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MyndMove® therapy
Non-invasive Functional Electrical Stimulation (FES) technique with surface electrodes to stimulate from 3 to 8 muscles to create purposeful movements in one or both hands/arms
Device: MyndMove®
This FES therapy can be used as a short-term therapeutic intervention to help improve voluntary grasping function

Active Comparator: Intensive Conventional therapy
Using Conventional therapy which focuses exclusively on the purposeful movements in one or both hands/arms
Other: Conventional Therapy
Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed.




Primary Outcome Measures :
  1. To compare the efficacy of MyndMove® therapy vs intensive conventional therapy in improving upper extremity function as measured by Spinal Cord Independence Measure self-care sub score (SCIM-SC) [ Time Frame: Change from baseline to 6weeks to 14 weeks to 24weeks ]
    SCIM-SC is a disability scale that has been specifically developed to evaluate the functional outcomes of patients with traumatic and non-traumatic SCI. The SCIM-SC assesses function of self-care, which includes feeding, bathing, dressing and grooming.


Secondary Outcome Measures :
  1. Change in participant's upper limb and hand impairment and function using Graded Refined Assessment of Strength Sensibility and Prehension (GRASSP) [ Time Frame: Change from baseline to 6weeks to 14weeks to 24weeks ]
    This is a multi-modality test designed to assess the integration of sensorimotor hand and upper limb impairment and function. This test combines the features of several other tests that have been used to assess hand and upper limb function in the peripheral hand population

  2. Change in participant's reaching and grasping function with the Toronto Rehab Institute Hand Function Test (TRI-HFT) [ Time Frame: Change from baseline to 14 weeks to 24weeks ]

    A test developed to evaluate improvements in the gross motor function of the unilateral grasp due to FES for reaching and grasping treatment. Hand functions that will be tested with the TRI-HFT are: lateral or pulp pinch, and palmar grasps.

    that have been used to assess hand and upper limb function in the peripheral hand population


  3. Change in participant's grasp, grip, pinch and gross movement of the arm and upper limb using the Action Research Arm Test (ARAT). [ Time Frame: Change from baseline to 14 weeks to 24weeks ]
    A test developed to assess the upper limb function in stroke and SCI patients. It consists of four sub-tests: grasp, grip, pinch and gross movement.

  4. Changes in the Modified Ashworth Scale (MAS) [ Time Frame: Change from baseline to 14 weeks to 24weeks ]
    A clinical assessment that measure of muscle spasticity in patients with neurological conditions

  5. To assess safety as measured by serious and non serious adverse events (SAEs) recorded for participants in both groups of the study population over the duration of the study [ Time Frame: Duration of the trial from baseline to 24weeks ]
  6. Change in quality of life as measured by the Spinal Cord Injury-Quality of Life (SCI-QOL) [ Time Frame: Change from baseline to 6weeks to 14weeks to 24weeks ]
    The SCI-QOL measurement system is a multifaceted system of measuring patient reported outcomes across a wide variety of functioning specifically targeted for individuals with SCI

  7. Change in quality of life as measured by the generic utility based measure EuroQol-EQ-5D-5L [ Time Frame: Change from baseline to 6weeks to 14weeks to 24weeks ]
    EQ-5D-5L™ is a standardized instrument for use as a measure of health outcome.It is applicable to a wide range of health conditions and treatments; it provides a simple descriptive profile and a single index value for health status. EQ-5D is a "Supplemental" Participation and Quality of Life outcome measure in the NINDS Spinal Cord Injury Common Data Elements guidance documents.



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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:

  1. Traumatic incomplete (AIS B-D) C4-C7 spinal cord injury
  2. Paralysis or paresis in both upper extremities
  3. At least 4 months (120 days) and less than 1 year (365 days) post traumatic SCI
  4. Baseline SCIM-SC ≤ 10
  5. From an outpatient care setting
  6. Able to understand and follow instructions
  7. Able to tolerate being in a seated position for a least one hour required to deliver upper limb therapy
  8. Willing to attend treatment sessions and all assessment sessions
  9. Able to understand and provide informed consent
  10. Men and women of the age of maturity in their Province or State

Exclusion Criteria:

  1. Previous history of any other neuromuscular disorder or conditions that may affect motor response
  2. Upper extremity injury or condition prior to SCI that limits the function of the hand or arm
  3. Malignant skin lesion on the affected upper extremity
  4. Rash or open wound at any potential electrode site
  5. History of seizure disorder not effectively managed by seizure medications
  6. An existing electrical stimulation devices (e.g. Implantable Cardiac Defibrillator, Pacemaker, Spinal Stimulation)
  7. Complete denervation of muscles that are targeted by MyndMove such that MyndMove® is unable to elicit tetanic muscle contraction when upper limits of stimulation intensity for the targeted muscle are applied.
  8. Poorly controlled autonomic dysreflexia (as determined by the local site physician)
  9. Modified Ashworth Scale (MAS) score of 4 of finger flexors, or finger extensors or wrist flexors or wrist extensors or biceps or triceps.
  10. History of psychiatric illness requiring hospitalization within past 24 months
  11. Active drug treatment for dementia
  12. Life expectancy of less than 12 months due to other illness
  13. In the judgment of the medical provider, participant has medical complications that may interfere with the execution of the study
  14. Currently enrolled in another upper limb study
  15. Enrolled, in the past six months, in a clinical study involving drugs or biologics

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): NCT03439319


Contacts
Contact: Darshika Mistry, BSc 905-363-0564 ext 223 darshika@myndtec.com

Locations
United States, Michigan
Rehabilitation Institute of Michigan, Detroit Medical Center/Wayne State University Not yet recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Lawrence Horn, M.D. MRM         
Sub-Investigator: Sujay Galen, PT, PhD, FHEA         
Sub-Investigator: Scott Millis, PhD, MEd         
United States, Texas
TIRR Memorial Hermann Not yet recruiting
Houston, Texas, United States, 77030
Principal Investigator: Argyrios Stampas, MD         
Canada, British Columbia
GF Strong Rehabilitation Centre Not yet recruiting
Vancouver, British Columbia, Canada
Principal Investigator: Andrea Townson, FRCPC, MScHPEd         
Canada, Ontario
Toronto Rehabilitation Institute Not yet recruiting
Toronto, Ontario, Canada
Principal Investigator: Kristin Kristin Musselman, PT, PhD         
Sponsors and Collaborators
MyndTec Inc.
U.S. Army Medical Research Acquisition Activity
United States Department of Defense
Programs for Assessment of Technology in Health Research Institute
McMaster University
Investigators
Study Director: Steve Plymale MyndTec Inc.

Responsible Party: MyndTec Inc.
ClinicalTrials.gov Identifier: NCT03439319     History of Changes
Other Study ID Numbers: MM-SCI-4002
CDMRP-SC150251 ( Other Grant/Funding Number: Congressionally Directed Medical Research Programs(CDMRP) under Spinal Cord Injury Research Program, US Dept of Defense )
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by MyndTec Inc.:
MyndMove
Electrical neuromodulation
conventional therapy

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Trauma, Nervous System
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases