Task-specific Epidural Stimulation Study
Task and Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing Using Epidural Stimulation and Training After Severe Spinal Cord Injury
University of Louisville
36 participants
Nov 8, 2017
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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 Criteria9
- 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
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Interventions
Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord. Participants received mapping for cardiovascular stability.
Participants undergo approximately 4 months of epidural stimulation for cardiovascular stability, daily.
Participants undergo approximately 4 months of epidural stimulation for voluntary movement 4-7 days weekly.
Participants undergo approximately 4 months of epidural stimulation for cardiovascular stability, daily. Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame with epidural stimulation for standing up to 5 days weekly.
Participants undergo approximately 4 months of epidural stimulation for voluntary movement, 4-7 days weekly. Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame with epidural stimulation for standing up to 5 days weekly. Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame with epidural stimulation for standing up to 5 days weekly.
Locations(1)
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NCT03364660