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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Injuries, Trauma, Nervous System

Intervention / Treatment
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* Device: MyndMove®
* Other: Conventional Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Traumatic incomplete (AIS B-D) C4-C7 spinal cord injury Paralysis or paresis in both upper extremities At least 4 months (120 days) and less than 96 months (2,920 days) post traumatic SCI Baseline SCIM-SC ≤ 10 From an inpatient or outpatient care setting Able to understand and follow instructions Able to tolerate being in a seated position for a least one hour required to deliver upper limb therapy Willing to attend treatment sessions and all assessment sessions Able to understand and provide informed consent Male and female participants ≥ 18 years of age at the time of enrollment Exclusion Criteria: Previous history of any other neuromuscular disorder or conditions that may affect motor response Upper extremity injury or condition prior to SCI that limits the function of the hand or arm Malignant skin lesion on the affected upper extremity Rash or open wound at any potential electrode site History of seizure disorder not effectively managed by seizure medications 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.) 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 Poorly controlled autonomic dysreflexia (as determined by the local site physician) History of psychiatric illness requiring hospitalization within the past 24 months Active drug treatment for dementia Life expectancy of less than 12 months due to other illness In the judgment of the medical provider, the participant has medical complications that may interfere with the execution of the study Currently enrolled in another upper limb study and/ or has received MyndMove Therapy within the past 3 months Enrolled, in the past six months, in a clinical study involving drugs or biologics Currently dependent on a ventilator 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 Females who are pregnant or planning to become pregnant in the duration of the trial Regional disorder of the upper extremities such as fracture, dislocation, or joint contractures to less than 50% of the expected range of motion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A two-arm, parallel group, multicentre, single-blind, randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MyndMove® therapy<br>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®<br>* This FES therapy can be used as a short-term therapeutic intervention to help improve voluntary grasping function<br>|
| Active Comparator: Intensive Conventional therapy<br>Using Conventional therapy which focuses exclusively on the purposeful movements in one or both hands/arms | Other: Conventional Therapy<br>* Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | Change from baseline to 6weeks to 14 weeks to 24weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in participant's upper limb and hand impairment and function using Graded Refined Assessment of Strength Sensibility and Prehension (GRASSP) | 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 from baseline to 6weeks to 14weeks to 24weeks | 
| Change in participant's reaching and grasping function with the Toronto Rehab Institute Hand Function Test (TRI-HFT) | 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 from baseline to 14 weeks to 24weeks | 
| 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 |  | 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) | 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 from baseline to 6weeks to 14weeks to 24weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MyndMove, Electrical neuromodulation, conventional therapy