Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT03364660
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03364660
Study Brief:
Protocol Section:
NCT03364660