Actively Recruiting
Task-specific Epidural Stimulation Study
Led by University of Louisville · Updated on 2024-08-28
36
Participants Needed
1
Research Sites
372 weeks
Total Duration
On this page
Sponsors
U
University of Louisville
Lead Sponsor
C
Christopher Reeve Paralysis Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Task-specific Epidural Stimulation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 persistent low blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension and/or blood pressure dysregulation with postural changes and/or highly variable blood pressures in 24 hours
- 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
You will not qualify if you...
- 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 or urostomy
- Any implanted pump such as baclofen or pain pump
- Ongoing nicotine use
- Pregnant at enrollment or planning pregnancy during the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
S
Susan J Harkema, PhD
CONTACT
M
Manpreet A Chopra, BAMS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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