Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery After Spinal Cord Injury

The goal of this clinical trial is to investigate the effects of transcutaneous spinal cord stimulation (TSCS) combined with exoskeleton training, as compared to exoskeleton training alone to improve motor function in individuals with incomplete spinal cord injury who are 12 months or less post-injury. Participants will be randomly assigned to a treatment group (exoskeleton training with TSCS, or exoskeleton training without TSCS). Participants in both groups will undergo a baseline evaluation, then take part in 24, 1-hour training sessions at Craig Hospital. After the 24 sessions have concluded, participants will undergo a post-treatment evaluation as well as a follow-up evaluation four weeks after training is completed. Researchers will compare the two groups by evaluating the following areas: walking ability and speed lower extremity strength, activation, and spasticity trunk control bowel and bladder function

Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a therapeutic level of transcutaneous spinal cord stimulation (TSCS) thoracolumbar spinal cord areas. Focus will be on stepping at a high intensity throughout the session as measured by heart rate.

Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a non-therapeutic level of stimulation (considered to be a sham). Focus will be on stepping at a high intensity throughout the session as measured by heart rate.

Participants will receive TSCS delivered with the ONWARD Lift system at 1ms using a 10kHz carrier frequency delivered at 30Hz, with an amplitude set for each participant based on their ability to increase voluntary movement output.

The ONWARD Lift system will also be used to deliver sham stimulation which will also be delivered at 1ms using a 10kHz carrier frequency delivered at 30Hz, and an amplitude of 1ma which has been used in other sham stimulation protocols and is not sufficient to induce activation of lumbosacral neuronal pools.

Assesses the amount of physical assistance/devices needed for walking following paralysis from SCI (scale of 0-20 with higher score indicating less need for assistance)

Participants walk a ten-meter track; time to walk the middle six meters is recorded and converted to meters/second (speed)

Assesses strength in 10 lower extremity muscle groups (each muscle scored 0-5 with higher score for greater strength; total score ranges 0-50.

Self-report measure of perception of spasticity frequency (0 to 5 scale with higher score more frequent spasms) and severity (1-3 scale with higher score more severe spasms)

Symptom based questionnaire evaluating bowel dysfuntion and its impact on quality of life (score 0-47 with higher score indicating greater bowel dysfunction)

Symptom based questionnaire evaluating bladder function and its impact on quality of lifehe Neurogenic Bladder Symptom Score (NBSS) is a validated 24 item questionnaire that measures bladder symptoms across 3 different domains: incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23); there is a single general urinary QOL question scored from 0 (pleased) to 4 (unhappy

Assesses static, proactive, and reactive balance as well as sensory integration. Each area assessed on scale of 0-4 with higher score indicating more independent trunk control.

Inclusion Criteria: < 12 months post traumatic iSCI C4-T10 with signs of upper motor neuron injury AIS B, C or D classification 18 years and older Height 5'0" to 6'4" Weight 220lbs or less Sufficient upper extremity strength to manage a stability aide Medical clearance for high intensity gait training Walking <1.46 m/s Intact skin in on pelvis, lower extremities and back Passive range of motion at shoulders, trunk, hips, knees & ankles within functional limits Exclusion Criteria: Unstable or symptomatic cardiac or respiratory issues Recent history of fracture, contractures, pressure injury, deep vein thrombosis, or other infection that might interfere with participation in study Received Botox injections to the lower extremities within the last six months Pregnancy Colostomy bag Cauda Equina injury Any other issue that in the opinion of the investigator would impact study participation Non-English Speaking