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

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

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.

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