Task-specific Epidural Stimulation Study (TS EPI)
Spinal Cord Injuries
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Epidural Stimulation, Spinal Cord Injury, Task-Specific
Eligibility Criteria
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
Sites / Locations
- University of LouisvilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Voluntary Movement Epidural Stimulation
Cardiovascular Epidural Stimulation
Voluntary Movement ES + Stand Training
Cardiovascular ES + Stand Training
Participants assigned to this group will receive epidural stimulation specific for voluntary movement.
Participants assigned to this group will receive epidural stimulation specific for cardiovascular function.
Participants assigned to this group will receive epidural stimulation specific for voluntary movement and will also receive stand training.
Participants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training.