Wearable Electrical Stimulation on the Back to Modulate Spinal Cord Activity

The goal of this study is to evaluate if non-invasive electrical spinal stimulation can help people with paralysis caused by SCI improve strength and function of their arms, legs, hands or feet. The study will involve therapy sessions involving exercises done at the same time as electrical stimulation therapy. This study has multiple parts to evaluate the effectiveness and safety of "smart" electrical stimulation of the spinal cord, which involves stimulating the spinal cord at precise locations and times to improve movement and function.

Inclusion Criteria:Has a non-progressive or central cord spinal cord injury from C2-T10 inclusiveHas American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or DCan participate in physical and occupational therapy rehabilitation programsIs at minimum 12 months post- spinal cord injuryCan provide informed consentHas adequate caregiver support to facilitate participation in studyExclusion Criteria:Has uncontrolled cardiopulmonary disease or cardiac symptoms (as determined by the Investigator)Has diffuse lower motor neuron injury rendering majority of muscles not excitableHas any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations like severe neuropathic pain, depression, mood disorders or other cognitive disordersHas autonomic dysreflexia that is severe, unstable, and uncontrolled or uncontrolled orthostatic hypotension that may interfere with rehabilitation.Requires ventilator supportHas an autoimmune etiology of spinal cord dysfunction/injuryHas spasms that limit the ability to participate in the study training (as determined by the Investigator)Has skin breakdown in area(s) that will come into contact with electrodesHas any active implanted medical deviceIs pregnant, planning to become pregnant or currently breastfeedingHas concurrent participation in another drug or device trial that may interfere with this studyHas other traumatic injuries such as peripheral nerve injuries, severe musculoskeletal injuries (e.g., shattered pelvis, long bone fractures), that prevent evaluation of response to or participation in rehabilitation.Is deemed ineligible because the investigators believe the study would not be safe or appropriate for the individual