E-STAND: Long-Term Outcomes Study

This study is a long term continuation of E-STAND. The study is assessing the long term effects of epidural spinal cord stimulation in those with chronic motor complete spinal cord injury and paraplegia. The goal of this trial is to test and optimize the use of epidural spinal cord stimulation to restore volitional movement in patients that have already had an epidural stimulator placed. We are now enrolling patients in our trial.

ClinicalTrials.gov identifier number (NCT Number): NCT05705453

Prescreening Questions

Collaborators for this study:

Andrei Krassioukov, MD, PhD, FRCPC

Aaron Phillips, PhD

Inclusion Criteria:

  • 22 years of age or older
  • Able to undergo the informed consent process
  • Stable spinal cord injury
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5
  • No ventilator dependency within the last year
  • American Spinal Injury Association (AISA) imparement scale”A” or “B” in the absence of spinal cord stimulation
  • Medically stable in the judgment of the Principal investigator
  • Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgery
  • Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation
  • Spinal imaging of the stimulator system

Exclusion Criteria:

  • Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator
  • Use of botulinum toxin (Botox) injections in the previous six months
  • Clinically significant mental illness in the judgment of the principal investigator
  • Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator
  • Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI
  • Current Pregnancy
  • Current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.