Combined Therapeutic Air Mixture and Electrical Stimulation to Improve Breathing and Hand Function in Spinal Cord Injury

Ki vehet részt

• Male or female age 18-65 years old 113
• Non-progressive or central cord spinal cord injury from C2-T1 inclusive
• American Spinal Injury Association (ASIA) Impairment Scale or AIS classification B, C, or D
• >20% impairment in maximal inspiratory or expiratory pressure generation, relative to established normative values
• Able to participate in physical and occupational therapy rehabilitation programs
• Minimum 12 months post SCI
• Capable of providing informed consent
• Has adequate caregiver support to facilitate participation in study
• Willingness to undergo non-deidentifiable audio and/or visual recording

Ki nem vehet részt

• Concurrent participation in another drug or device trial that may interfere with this study
• Has uncontrolled cardiopulmonary disease or cardiac symptoms based on medical records and/or abnormal response to intervention
• Has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations (neuropathic pain, depression, mood disorders, cognitive disorders, etc.)
• Has any active implanted medical device, such as cardiac pacemaker
• Has diffuse lower motor neuron injury rendering majority of muscles not excitable
• Has autonomic dysreflexia that is severe, unstable, or uncontrolled
• Has uncontrolled orthostatic hypotension that may interfere with rehabilitation
• Requires ventilator support
• Has spasms that limit participation in study training as determined by the medical record and/or abnormal response to experimental treatment intervention
• Has skin breakdown in areas that will come in contact with electrodes or pressure injuries that prevent participation in physical functioning activities
• Has no EMG activity, observed via surface e-stim, in phrenic nerve nor at least three (3) hand/forearm muscles
• Pregnant, planning to become pregnant, or currently breastfeeding
• Has other traumatic injuries, such as peripheral nerve injuries, sever musculoskeletal injuries (e.g., shattered pelvis, long bone fractures) that prevent evaluation of response to or participation in rehabilitation
• Non-English speaker