Overview
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
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).
- Has a history of recent seizures or poorly managed autonomic dysreflexia that could be triggered by TMS or TSCS.
- Has a history of prior intracranial surgery or known lesions that would limit TMS assessments and Brain-Computer Interface (BCI) recordings.
- Individuals with metal implants in their head and other implantable devices in the body that could be affected by TMS or TSCS.
- Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.).
- Has urinary tract infection, unhealed fracture, contracture, and pressure sore (Braden Scale).
- Has breakdown in skin area that will come into contact with electrodes.
- Individuals who require therapy or other care that could interfere with participation in the study.
- Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function.
- Individuals with substance disorders, including alcoholism and drug abuse.
- Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study.
- In the opinion of the investigators, the study is not safe or appropriate for the participant.