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
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.
Description
Experimental Design The investigators will enroll, implant and complete the interventions in 36 research participants who have sustained a SCI in the proposed experiments. The investigators anticipate they will need to screen 108 potential research participants to enroll 36 individuals who will complete the study. This sample size will provide sufficient replication per study group (n=4) from which variance and effect size estimates for each study hypothesis can be calculated, and hypothesis tests conducted. The investigators will also select individuals to assure that there are a minimum of…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 v…
Interventions
- DeviceAcute epidural stimulation for cardiovascular stability
Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord. Participants received mapping for cardiovascular stability.
- DeviceLong Term Epidural Stimulation for Cardiovascular Stability
Participants undergo approximately 4 months of epidural stimulation for cardiovascular stability, daily.
- DeviceParticipants undergo approximately 4 months of epidural stimulation for voluntary movement.
Participants undergo approximately 4 months of epidural stimulation for voluntary movement 4-7 days weekly.
- DeviceLong Term Epidural Stimulation for Cardiovascular Stability plus Stand Training
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.
- Device
Location
- University of LouisvilleLouisville, Kentucky