Task-specific Epidural Stimulation Study
The investigators propose to understand the role of lumbosacral spinal cord epidural stimulation (scES) in recovery of autonomic nervous system function, voluntary movement, and standing in individuals with severe spinal cord injury (SCI). Thirty-six individuals with severe SCI who have cardiovascular and respiratory dysfunction and who are unable to voluntarily move the legs or stand will receive scES for cardiovascular function, voluntary movement, or standing with and/or without weight-bearing standing. Training will consist of practicing voluntary movements or standing in the presence of specific scES configurations designed for the voluntary movements of the legs and trunk (Vol-scES), or epidural stimulation configurations specific for standing (Stand-scES). Specific configurations epidural stimulation for cardiovascular function (CV-scES) will be provided during sitting and supine and during maneuvers of orthostatic or cardiovascular stress. The ability to move voluntarily, stand, as well as cardiovascular, respiratory, bladder, bowel and sexual function will be assessed in these individuals with chronic severe spinal cord injury. Quality of life and costs of health care also will be assessed.
Conditions:
🦠 Spinal Cord Injuries
🗓️ Study Start (Actual) 8 November 2017
🗓️ Primary Completion (Estimated) 30 December 2024
✅ Study Completion (Estimated) 30 December 2024
👥 Enrollment (Estimated) 36
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Louisville, Kentucky, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * At least 18 years of age
    • * Non-progressive spinal cord injury
    • * At least 2 years post injury
    • * Stable medical condition
    • * Unable to voluntarily move all individual joints of the legs
    • * Unable to stand independently
    • * Cardiovascular dysfunction including presence of persistent low blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension and/or dysregulation in response to postural changes and/or highly variable blood pressures in a 24 hour period
    • * Urodynamic dysfunction including dyssynergia and/or inability to void voluntarily and/or low voiding capacity
    • * Respiratory dysfunction including at least 15% deficit in predicted pulmonary function outcomes

    Exclusion Criteria:

    • * Ventilator dependent
    • * Untreated painful musculoskeletal dysfunction, fracture or pressure sore
    • * Untreated psychiatric disorder or ongoing drug abuse
    • * Cardiovascular, respiratory, bladder, or renal disease unrelated to spinal cord injury
    • * Bladder botox injections less than 12 months prior to implant
    • * Colostomy bag, urostomy
    • * Any implanted pump (i.e., baclofen pump, pain pump, etc)
    • * Ongoing nicotine use
    • * Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 November 2017
  • First Submitted that Met QC Criteria 30 November 2017
  • First Posted 6 December 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 July 2024
  • Last Update Posted 18 July 2024
  • Last Verified July 2024