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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT03441256
Eligibility Criteria:
Inclusion Criteria:
1. Willing and able to give informed consent for participation in the clinical investigation, and to comply with all requirements of the clinical investigation
2. Traumatic SCI with:
* neurological level below T5 and above L2
* American Spinal Injury Association Impairment Grade A or B
* spasticity in one or both lower extremities
* Injury prior at least 12 months prior to enrollment
Exclusion Criteria:
1. Female subject who is pregnant/planning pregnancy during the clinical investigation.
2. Previous surgery/procedures interfering with the LION procedure incl. the presence of other implanted medical devices.
3. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the clinical investigation, or may influence the result of the clinical investigation, or the subject's ability to participate in the clinical investigation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03441256
Study Brief:
Protocol Section:
NCT03441256