Wearable Electrical Stimulation on the Back to Modulate Spinal Cord Activity (RISES-T)
Spinal Cord Injuries, Spinal Cord Diseases
About this trial
This is an interventional device feasibility trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, Spinal Electrical Stimulation, Transcutaneous Spinal Stimulation
Eligibility Criteria
Inclusion Criteria: Has a non-progressive or central cord spinal cord injury from C2-T10 inclusive Has American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D Can participate in physical and occupational therapy rehabilitation programs Is at minimum 12 months post- spinal cord injury Can provide informed consent Has adequate caregiver support to facilitate participation in study Exclusion Criteria: Has uncontrolled cardiopulmonary disease or cardiac symptoms (as determined by the Investigator) Has diffuse lower motor neuron injury rendering majority of muscles not excitable 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 autonomic dysreflexia that is severe, unstable, and uncontrolled or uncontrolled orthostatic hypotension that may interfere with rehabilitation. Requires ventilator support Has an autoimmune etiology of spinal cord dysfunction/injury Has 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 electrodes Has any active implanted medical device Is pregnant, planning to become pregnant or currently breastfeeding Has concurrent participation in another drug or device trial that may interfere with this study Has 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
Sites / Locations
- Thomas Jefferson University
Arms of the Study
Arm 1
Experimental
Treatment Arm
Participants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing functional task practice in occupational therapy sessions.