Ensayos clínicos

Inclusion Criteria:

• At least 22 years old and no older than 75 years old at the time of enrollment.
• Non-progressive cervical spinal cord injury from C2-C8 inclusive.
• American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D.
• Indicated for upper extremity training procedures by subject's treating physician or a physical therapist.
• Baseline GRASSP-Prehension score ≥ 10 or GRASSP-Strength score ≥ 30.
• Minimum 12 months post-injury.
• Titration of baclofen to 10 mg or less at night.
• On stable spasticity and pain medications for at least 4 weeks prior to enrollment.
• Capable of providing informed consent.

Exclusion Criteria:

• Has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the Investigator.
• Has 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 disorders.
• Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled.
• Requires ventilator support.
• Has an autoimmune etiology of spinal cord dysfunction/injury.
• Previously diagnosed as having transverse myelitis.
• History of additional neurologic disease such as stroke, multiple sclerosis, traumatic brain injury, etc.
• Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.).
• Spasms that limit the ability of the subjects to participate in the study training as determined by the Investigator.
• Received Botulinum toxin injections in their upper extremity, neck or hand within 6 months prior to enrollment.
• Has painful musculoskeletal dysfunction unrelated to SCI, unhealed fracture, contracture, pressure sore, or urinary tract infection at time of enrollment.
• Breakdown in skin area that will come into contact with electrodes.
• Presence of syringomyelia as confirmed by an MRI.
• Currently undergoing treatment for cancer or has been in remission for less than 2 years.
• Received stem cell treatment within the past two years prior to enrollment.
• Has any active implanted medical device.
• Pregnant, planning to become pregnant or currently breastfeeding.
• Concurrent participation in another drug or device trial that may interfere with this study.
• Has undergone a prior course of NESS therapy directed at UE improvement.
• In the opinion of the investigators, the study is not safe or appropriate for the participant.