Spinal Cord Injuries, Trauma, Nervous System
Conditions
Keywords
MyndMove, Electrical neuromodulation, conventional 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.
Interventions
DEVICEMyndMove®
This FES therapy can be used as a short-term therapeutic intervention to help improve voluntary grasping function
OTHERConventional Therapy
Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed.
Sponsors
U.S. Army Medical Research Acquisition Activity
United States Department of Defense
Programs for Assessment of Technology in Health Research Institute
McMaster University
MyndTec Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A two-arm, parallel group, multicentre, single-blind, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in participant's upper limb and hand impairment and function using Graded Refined Assessment of Strength Sensibility and Prehension (GRASSP) | 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) | 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 | 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) | 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 |
Countries
Canada, United States
Outcome results
None listed