Spinal Cord Injuries
Conditions
Brief summary
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.
Interventions
OTHERTranscutaneous Spinal Cord Stimulation and Gait Training
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.
Sponsors
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
All assessors will be blind to intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in walking speed | at the start, week 4, and week 8 | 10-Meter Walk Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in walking capacity | at the start, week 4, and week 8 | Timed Up and Go |
| Change in level of assistance and assistive device for walking | at the start, week 4, and week 8 | Walking Index for Spinal Cord Injury II |
| Change in walking endurance | at the start, week 4, and week 8 | 6-Minute Walk Test |
Countries
United States
Outcome results
None listed