The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury

Study Overview
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Brief Summary
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Aim 1: Determine the neurophysiologic impact of Transcutaneous Spinal Cord Stimulation (TSCS) within a single session. The investigators hypothesize that subjects will demonstrate increased volitional muscle activity and strength with TSCS. This will be assessed by surface EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (MVC) and measurement of gait speed. Subjects will be tested in both TSCS and sham conditions. Aim 2: Determine the impact of TSCS and gait training on walking function. The investigators hypothesize that concurrent TSCS and gait training will augment walking function in subjects with iSCI, as compared to gait training alone. Subjects will participate in an eight-week program of gait training with TSCS and be assessed with clinically relevant outcome measures, to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test.

Official Title
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The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Transcutaneous Spinal Cord Stimulation and Gait Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old >1 year post SCI Non-progressive SCI Neurological level above T10 Tolerates upright position for >30 minutes Medically stable (no hospitalizations in last 3 months) Able to comply with procedures and follow up Are legally able to make their own health care decisions Exclusion Criteria: Progressive SCI/D (MS, ALS, ADEM, etc.) Open wounds at stimulation site Pregnant women ROM limitations impacting gait training Cardiac pacemaker/defibrillator Active cancer diagnosis Currently receiving TSCS Evidence of uncontrolled autonomic dysreflexia Non-English speaking subjects will not be targeted

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TSCS and gait training<br> | Other: Transcutaneous Spinal Cord Stimulation and Gait Training<br>* TSCS will be applied using a midline electrode placed on the skin between spinous process T11 -T12 and two electrodes placed symmetrically on the skin over the lower abdomen as anodes. A symmetrical biphasic rectangular waveform, at 50 Hz and 1 millisecond, is used to provide 30 continuous minutes of stimulation. Subjects will participate in 24 two-hour sessions of physical therapy over eight weeks. In each session, subjects will receive TSCS continuously for 30 minutes, using the parameters outlined above. During stimulation, subjects will participate in strengthening, segmental task practice, and gait-based interventions. Participation in gait training will continue following the stimulation period for the duration of the session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in walking speed | 10-Meter Walk Test | at the start, week 4, and week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in walking capacity | Timed Up and Go | at the start, week 4, and week 8 | 
| Change in level of assistance and assistive device for walking | Walking Index for Spinal Cord Injury II | at the start, week 4, and week 8 | 
| Change in walking endurance | 6-Minute Walk Test | at the start, week 4, and week 8 |