Status:
RECRUITING
Task-specific Epidural Stimulation Study
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
Christopher Reeve Paralysis Foundation
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 individual...
Detailed 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 anticipat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03364660
Start Date
November 8 2017
End Date
December 30 2024
Last Update
August 28 2024
Active Locations (1)
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1
University of Louisville
Louisville, Kentucky, United States, 40202