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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 : 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.

Study Description
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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.

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

Study Design
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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
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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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. 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 ]
  4. 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


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

Locations
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United States, Ohio
MetroHealth Medical Center / Louis Stokes Cleveland VA Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Kimberly    216-957-3558      
Principal Investigator: Kimberly Anderson, PhD         
Sub-Investigator: James Wilson, DO         
United States, Texas
TIRR Memorial Hermann Recruiting
Houston, Texas, United States, 77030
Contact: Ruta    713-799-6976      
Principal Investigator: Radha Korupolu, MD         
Sub-Investigator: Nuray Yozbatiran, PhD, PT         
Canada, British Columbia
HealthTech Connex Centre for Neurology Studies / NeuroMotion Physiotherapy Clinics ( Surrey, Vancouver and Victoria) Recruiting
Surrey, British Columbia, Canada, V3V 0C6
Contact: Natasha    778-874-7758      
Principal Investigator: Jacqueline Pierce, MD, FRCP(C)         
Canada, Ontario
Toronto Rehabilitation Institute 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
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Study Director: Steve Plymale MyndTec Inc.
More Information
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Responsible Party: MyndTec Inc.
ClinicalTrials.gov Identifier: NCT03439319    
Other Study ID Numbers: MM-SCI-4002
CDMRP-SC150251 ( Other Grant/Funding Number: Congressionally Directed Medical Research Programs(CDMRP),Spinal Cord Injury Research Program, US Dept of Defense )
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by MyndTec Inc.:
MyndMove
Electrical neuromodulation
conventional therapy
Additional relevant MeSH terms:
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Spinal Cord Injuries
Trauma, Nervous System
Wounds and Injuries
 Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases