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:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT04130295
Eligibility Criteria:
Inclusion Criteria:
* Be 18-65 years of age
* Have sustained cervical or thoracic SCI at least 6 months prior to initiating participation in study
* Any ISNCSCI severity classification (A, B, C, or D)
* Have self-reported spasticity and at the time of screening demonstrate an FSE angle of ≤ 75 degrees on the pendulum test or ≥ 4 beats of clonus on the drop test
* May participate if utilizing oral prescription medications for control of spasticity
* Ability and willingness to consent and authorize use of personal health information
Exclusion Criteria:
* Severe contractures of the leg/foot to be stimulated (decided during pre-assessment) that limit passive movement of the hip, knee, or ankle more than 50% of normal range of motion or presence of other orthopedic pathology that would adversely influence participation in the protocol
* Any implanted catheter such as but not limited to CSF shunt, baclofen pump, or the presence of a pacemaker, implanted automatic internal cardioverter defibrillator (AICD, other cardiac implants and or conditions)
* Severe pain or hypersensitivity of the leg to be stimulated (decided during pre-assessment)
* Uncontrolled edema of the leg to be stimulated (decided during pre-assessment)
* Current pregnancy
* Lumbar spinal cord injury level
* Inability or unwillingness to consent and authorize use of personal health information
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04130295
Study Brief:
Protocol Section:
NCT04130295