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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03439319
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : April 20, 2020
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.

Tracking Information
First Submitted Date  ICMJE February 13, 2018
First Posted Date  ICMJE February 20, 2018
Last Update Posted Date April 20, 2020
Actual Study Start Date  ICMJE June 3, 2019
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • 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
  • 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
  • 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 ]
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
  • 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
  • hange 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
  • 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.
  • 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
  • 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 ]
  • 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
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Restoration of Reaching and Grasping Function in Individuals With Spinal Cord Injury Using MyndMove® Neuromodulation Therapy
Official Title  ICMJE Restoration of Reaching and Grasping Function in Individuals With Spinal Cord Injury Using MyndMove® Neuromodulation Therapy
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, traumatic spinal cord injury.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Spinal Cord Injuries
  • Trauma, Nervous System
Intervention  ICMJE
  • Device: MyndMove®
    This FES therapy can be used as a short-term therapeutic intervention to help improve voluntary grasping function
  • Other: Conventional Therapy
    Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed.
Study Arms  ICMJE
  • 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
    Intervention: Device: MyndMove®
  • Active Comparator: Intensive Conventional therapy
    Using Conventional therapy which focuses exclusively on the purposeful movements in one or both hands/arms
    Intervention: Other: Conventional Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 13, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 96 months (2,920 days) post traumatic SCI
  4. Baseline SCIM-SC ≤ 10
  5. From an inpatient or 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. Male and female participants ≥ 18 years of age at the time of enrollment

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 implanted metallic part (e.g. plates, screws or joint replacement) or electrical device (e.g. Implantable Cardiac Defibrillator, Pacemaker, Spinal Stimulation). (Note: If the participant has passive metallic implants, the therapy can be delivered if the implants are located in an area other than where the electrical stimulant is to be delivered.)
  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. History of psychiatric illness requiring hospitalization within the past 24 months
  10. Active drug treatment for dementia
  11. Life expectancy of less than 12 months due to other illness
  12. In the judgment of the medical provider, the participant has medical complications that may interfere with the execution of the study
  13. Currently enrolled in another upper limb study and/ or has received MyndMove Therapy within the past 3 months
  14. Enrolled, in the past six months, in a clinical study involving drugs or biologics
  15. Currently dependent on a ventilator
  16. Botulinum toxin injection into affected upper extremity and the muscle targeted by MyndMove® therapy within 6 months prior to the study start. No botulinum toxin injections in the upper extremity during the study treatment and follow up period
  17. Females who are pregnant or planning to become pregnant in the duration of the trial
  18. Regional disorder of the upper extremities such as fracture, dislocation, or joint contractures to less than 50% of the expected range of motion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Darshika Mistry, BSc 905-363-0564 ext 223 darshika@myndtec.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03439319
Other Study ID Numbers  ICMJE MM-SCI-4002
CDMRP-SC150251 ( Other Grant/Funding Number: Congressionally Directed Medical Research Programs(CDMRP),Spinal Cord Injury Research Program, US Dept of Defense )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MyndTec Inc.
Study Sponsor  ICMJE MyndTec Inc.
Collaborators  ICMJE
  • U.S. Army Medical Research Acquisition Activity
  • United States Department of Defense
  • Programs for Assessment of Technology in Health Research Institute
  • McMaster University
Investigators  ICMJE
Study Director: Steve Plymale MyndTec Inc.
PRS Account MyndTec Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP