Epidural Stimulation After Neurologic Damage

Launched by UNIVERSITY OF MINNESOTA · Jan 17, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a technique called epidural spinal cord stimulation, which aims to help people with spinal cord injuries regain movement in their legs and improve other body functions, like blood pressure control. Researchers want to find the best settings for this treatment to see how it can help those with complete paraplegia, a condition where individuals cannot move their legs due to injury.

To participate in this study, you need to be at least 22 years old and have had a stable spinal cord injury for over a year, specifically between the neck and mid-back areas. The study is open to anyone who meets these criteria, regardless of gender. Participants will need to attend regular appointments and will undergo assessments to evaluate their progress. It's important to note that certain medical conditions or recent treatments may prevent someone from joining the trial, so a thorough health review will be conducted before enrollment. Overall, this trial could provide valuable insights into improving mobility and health for those affected by spinal cord injuries.

Gender

ALL

Eligibility 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