The E-STAND trial was made to formally test the use of epidural spinal cord stimulation for restoring volitional movement in the legs of patients who suffered spinal cord injury and have been unable to move since injury. In addition, the trial was constructed to figure out how to choose stimulation settings that provide the largest improvement in movement.
The E-STAND trial is also hoping to begin to understand how epidural spinal cord stimulation in this patient population can affect blood pressure, heart function, urinary function, bowel function and some aspects of cognitive function.
Take the prescreen survey here. Completing this survey will add you to our database of potential participants. People are chosen for in-person screening appointments in the order they complete and pass this prescreening survey. Once you complete the survey you will eventually be contacted through email by study staff about openings for enrollment and if you qualify for participation.
In order for patients to participate they must meet the inclusion and exclusion criteria:
Inclusion Criteria:
- 22 years of age or older
- Able to undergo the informed consent/assent process
- Stable, motor-complete paraplegia
- Discrete spinal cord injury between C6 and T10
- ASIA A or B Spinal Cord Injury Classification
- Medically stable in the judgement of the principal investigator
- Intact segmental reflexes below the lesion of injury
- Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation
- Willing to attend all scheduled appointments
Exclusion Criteria:
- Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery (e.g. cardiopulmonary issues)
- Inability to withhold antiplatelet/anticoagulation agents perioperatively
- Significant dysautonomia that would prohibit rehabilitation or assisted standing or any history of CVA or MI associated with autonomic dysreflexia.. A single tilt table test with syncope, presyncope, or SBP < 50 or >200.
- Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgement of the principal investigator
- Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgement of the principal investigator
- Clinically significant mental illness in the judgement of the principal investigator
- Botulinum toxin injections in the previous 6 months
- Volitional movements present during EMG testing in bilateral lower extremities
- Unhealed spinal fracture
- Presence of significant contracture
- Presence of pressure ulcers
- Recurrent urinary tract infection refractory to antibiotics
- Current Pregnancy