About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- BCI-TSCS
Treatment groups
Sponsors and collaborators
University of Miami
Lead sponsor
United States Department of Defense
Collaborator