The purpose of this research is to test the effectiveness of a new therapy, called Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS), for improving walking in people with an incomplete spinal cord injury (SCI).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. At least 18 years old and no older than 70 years old at the time of enrollment.
✓. Traumatic incomplete spinal cord injury (neurological level at or above T10 spinal cord level; Abbreviated Injury Scale (AIS) C or D impairment grade for group 1, 3 and 4 and AIS B, C or D impairment grade for group 2), who are more than 6 months post-injury.
✓. Has detectable motor function in at least 2 muscles per side confirmed by voluntary Electromyography (EMG) or detectable tibialis anterior (TA) muscle motor evoked potentials (MEPs) at the baseline assessment.
✓. Able to commit to intensive training and assessment sessions over a maximum total duration of 6 months.
✓. Could effectively walk overground for at least 10 meters with some assistance of a therapist and minimal body-weight support, with functional spasticity (by participant's self-report), functional range-of-motion of lower limb joints, and acceptable bone mass to enable body-weight support, confirmed by Dual-energy X-ray absorptiometry (DXA) scan.
Exclusion criteria
✕. Has traumatic brain injury, stroke, multiple sclerosis, or other neuromuscular disorders that could affect neuromotor function and walking.
✕. Has severe spasticity that could prevent stepping and walking function determined by the investigator.
✕. Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
✕. Has other contra-indications for transcranial magnetic stimulation (TMS) or Transcutaneous Spinal Cord Stimulation (TSCS).
What they're measuring
1
Number of related neurological deterioration (LEMS)
Timeframe: up to 12 months
2
Number of treatment related incidence of adverse events (AEs)