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

Study Overview
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Brief Summary
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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

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

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: Exo + TSCS
* Device: Exo + Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: < 12 months post traumatic iSCI C4-T10 with signs of upper motor neuron injury AIS 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 Cauda Equina injury Any other issue that in the opinion of the investigator would impact study participation Non-English Speaking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exoskeleton+Transcutaneous Spinal Cord Stimulation<br>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. | Device: Exo + TSCS<br>* 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.<br>|
| Sham Comparator: Exoskeleton+Sham Stimluation<br>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. | Device: Exo + Sham<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score on Walking Index for SCI (WISCI) II | 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) | Baseline to Immediately After Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in walking speed as measured by the 10 Meter Walk Test | Participants walk a ten-meter track; time to walk the middle six meters is recorded and converted to meters/second (speed) | Baseline to Immediately After Intervention | 
| Change in distance walked as measured by the 6 Meter Walk Test | Measures distance walked (in meters) over 6 minute time period | Baseline to Immediately After Intervention | 
| Change in lower extremity strength as measured by Lower Extremity Motor Score (LEMS) | Assesses strength in 10 lower extremity muscle groups (each muscle scored 0-5 with higher score for greater strength; total score ranges 0-50. | Baseline to Post-treatment | 
| Change in spasm frequency and severity as measured by Penn Spasm Frequency | 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) | Baseline to Immediately After Intervention | 
| Change in bowel function as measured by Neurogenic Bowel Dysfunction Scale | Symptom based questionnaire evaluating bowel dysfuntion and its impact on quality of life (score 0-47 with higher score indicating greater bowel dysfunction) | Baseline to Immediately After Intervention | 
| Change in bladder function as measured by Neurogenic Bladder Symptom Scale | 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 | Baseline to Immediately After Intervention | 
| Change in balance/trunk control as measure by the Function in Sitting Test Spinal Cord Injury | 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. | Baseline to Immediately After Intervention |