Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities. The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation (tSCS) for cardiovascular recovery in adults aged 21-65 following chronic motor-complete spinal cord injury (SCI) at or above the thoracic sixth spinal segment (≥T6).
The main questions the study aims to answer are:
* Conduct tSCS mapping to determine the most effective location and stimulation intensity for BP control in individuals with motor-complete SCI ≥ T6. * Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to sham stimulation with exercise on improving cardiovascular function in individuals with motor-complete SCI ≥T6. * Evaluate the dosage-response of 8 weeks vs. 16 weeks of targeted tSCS paired with arm-crank exercise on cardiovascular function in individuals with motor-complete SCI ≥T6. * Explore the mechanisms involved in cardiovascular recovery with long-term tSCS paired with arm-crank exercise.
Participants will:
* Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while exercising on an arm-crank bicycle in the first 8 weeks. * Come in for approximately 60 visits over a 6-month period. This includes 2, 8-week periods where the investigators will ask participants to come in 3x per week for spinal cord stimulation and exercise. * During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, physical, and autonomic exam, and will ask questions about quality of life and functioning. Assessment procedures also include stool sample and nasal swab collection.
Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those who receive a sham stimulation and do moderate arm-crank exercise to see if tSCS is effective at improving cardiovascular and autonomic functioning in those with SCI.
Are between 21-65 years of age.
Chronic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal cord segment.
Greater than ten months post injury or diagnosis, at least 6 months from any spinal surgery.
American Spinal Injury Association Impairment Scale (AIS) A, B for SCI.
Have autoimmune etiology of spinal cord dysfunction/injury
Have history of additional neurologic disease, such as stroke, MS, traumatic brain injury, etc.
Have peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
Have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
Parallel
Transcutaneous Spinal Cord Stimulation
DeviceNon-invasive electrical stimulation of the spinal cord over the skin
Arm-crank bike exercise
BehavioralExercise using an arm-bike to target cardiovascular functioning.
Sham Stimulation
Other interventionNon-invasive electrical stimulation of a lower extremity muscle group over the skin.
Change in systolic Blood Pressure (BP) from baseline.
Continuous beat-by-beat BP will be measured using a finger photoplethysmography.
Change in systolic Blood Pressure during a sit-up test or head-up tilt test.
Continuous beat-by-beat BP will be measured during a orthostatic challenge.
Heart rate variability recorded by electrocardiogram (ECG).
Parameters using RR intervals (R-wave peak to R-wave peak in electrocardiogram) processed to assess the activity of autonomic nervous system.
Peak oxygen uptake (VO2peak)
Measured during incremental cardiopulmonary exercise test (CPET) on the arm-crank.
Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure
The Autonomic Dysfunction following SCI (ADFSCI) measure will be used to assess severity and frequency of autonomic dysreflexia. Greater scores equal greater frequency of autonomic dysfunction, ranging from 0 (never) to 4 (very often) for each item.
International Standards for Neurological Classification of Spinal Cord Injury
level and severity of damage to motor and sensory pathways will be determined by trained clinicians. Pin prick and light touch will be done by researchers on participant's left and right side. Check marks are given for each prick or touch that is felt by the participant, then tallied. Scores range from 0-56 for both the Left and Right side of the body, and 0-112 for the total score. High scores represent greater sensory functioning.
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)
Scores for questions on the ISAFSCI range from 0 to 2, with 0 representing complete loss of control and 2 representing normal functioning. Lower scores equal worse health functioning.
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