A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients

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

About this trial

The purpose of this research is to explore the effect of magnetic stimulation to activate the brain, electrical spinal cord stimulation to activate spinal cord, and electrical muscle stimulation used to activate upper limb (arms), lower limb (legs) and trunk (stomach) muscles in people with spinal cord injury (SCI) and able-bodied subjects (without SCI).

Eligibility criteria

Qualifiers

At least 18 years old and no older than 70 years old at the time of enrollment.

Able-bodied subjects

Traumatic spinal cord injury

Upper limb target: neurological level at or above Thoracic 1 level, Abbreviated Injury Scale (AIS) B, C or D impairment grade, primary non-ambulatory;

Disqualifiers

Has traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function.

Has severe spasticity that could prevent the study protocol as determined by the investigator.

Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.

Has contraindications for transcutaneous stimulation using FES or TSCS such as breakdown of skin in the area that will come into contact with electrodes, thrombosis, or skin disease.

Trial design

Treatments tested in this trial

  • Intermittent theta burst stimulation (iTBS)
  • Functional electrical stimulation (FES)
  • Transcutaneous spinal cord stimulation (TSCS)
  • Sham Intermittent theta burst stimulation (iTBS)

Treatment groups

25 Participants
are divided into 4 treatment groups

Sponsors and collaborators