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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT06650202
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years old
* Stable medical condition.
* Has a spinal cord injury caused by trauma (fall, car accident, etc.) for at least one year that is not getting worse over time
* Has an implanted spinal cord epidural stimulation unit that is eligible for software upgrade as part of a previous study.
* Unable to stand independently with epidural stimulation turned off.
Exclusion Criteria:
* unwilling to discontinue from anti-spasticity medications
* Untreated painful problems with joints, muscles or bones.
* Unhealed fracture.
* Pressure sore or urinary tract infection.
* History of bone disease (except for decreased bone mineral density due to spinal cord injury).
* Ongoing drug abuse.
* Untreated psychiatric disorders or clinical depression.
* Received Botox injections in the lower extremities in the prior six months.
* Heart or lung disease that may interfere with assessments.
* Untreated severe and persistent problems regulating blood pressure, heart rate, body temperature or other automatic functions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06650202
Study Brief:
Protocol Section:
NCT06650202