Brain-Controlled Spinal Stimulation Walking Therapy After Incomplete Spinal Cord Injury (SCI)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Miami

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

12 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Miami

Lead sponsor

United States Department of Defense

Collaborator