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RecruitingSpinal Cord Injuries

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

Eligible age

18–70 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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).

Sponsor: University of Miami

You may qualify if…

  • ✓ 1. At least 18 years old and no older than 70 years old at the time of enrollment.
  • ✓ 2. 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.
  • ✓ 3. 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.
  • ✓ 4. Able to commit to intensive training and assessment sessions over a maximum total duration of 6 months.
  • ✓ 5. 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.

You may not qualify if…

  • ✕ 1. Has traumatic brain injury, stroke, multiple sclerosis, or other neuromuscular disorders that could affect neuromotor function and walking.
  • ✕ 2. Has severe spasticity that could prevent stepping and walking function determined by the investigator.
  • ✕ 3. Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
  • ✕ 4. Has other contra-indications for transcranial magnetic stimulation (TMS) or Transcutaneous Spinal Cord Stimulation (TSCS).
  • ✕ 5. Has a history of recent seizures or poorly managed autonomic dysreflexia that could be triggered by TMS or TSCS.
  • ✕ 6. Has a history of prior intracranial surgery or known lesions that would limit TMS assessments and Brain-Computer Interface (BCI) recordings.
  • ✕ 7. Individuals with metal implants in their head and other implantable devices in the body that could be affected by TMS or TSCS.
  • ✕ 8. Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.).

Where it's recruiting

Florida

Miami

Source: ClinicalTrials.gov · NCT06406855 · last updated 2025-09-12

Brain-Controlled Spinal Stimulation Walking Therapy After Incomplete S · TrialPath