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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT01606618
Eligibility Criteria:
Inclusion Criteria:
* Patients with a spina bifida aperta or an acquired traumatic spinal cord injury dating more than two years, the level of injury being below D12 and higher S1 (Score ASIA A).
* Age between 18 and 60
* Knowing how to read, write, count
* Having given their free, informed and in writing consent (an information is also given to the reliable person when it exists)
* Affiliated to the National Health Service
Exclusion Criteria:
* Psychiatric history requiring an hospitalization in a specialized unit during more than two months
* Score MMS lower than 27 ( GRECO version)
* Serious associated pathology or associated pathology which could interfer with the management of vesico-sphincteral disorders
* Neurosurgery, dating from less than one year
* Symptoms of dysfunction of ventricular bypass valve at the time of inclusion
* Clinical epileptic attack within six months prior to inclusion
* Pregnancy or breastfeeding
* Simultaneous inclusion in an another therapeutic protocol or period of exclusion from an another protocol
* Traumatic spinal cord injury acquired before age 16
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01606618
Study Brief:
Protocol Section:
NCT01606618