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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT01600404
Eligibility Criteria:
Inclusion Criteria:
* acute traumatic spinal cord injury
* primary rehabilitation / in-house patient
* 18-65 years of age
* treatment group: indication for antimuscarinic treatment (oxybutynin, tolterodine
* willingness and motivation to participate in study
Exclusion Criteria:
* lesion level above C4
* traumatic brain injury (initial Glasgow Coma Score \< 13)
* pre-existing dementia
* pre-existing impaired cognitive function
* previous antimuscarinic treatment
* treatment group: antimuscarinic treatment other than oxybutynin, tolterodine
* acute psychologic disorders, diseases, schizophrenia
* alcohol abuse, consumption of illegal drugs (incl. marijuana)
* moderate to severe depression (Beck Depression Inventory Score \> 18)
* moderate to severe pain (International Spinal Cord Injury Pain Basic Data Set)
* progressive disease
* tricyclic antidepressant
* color blindness, impaired sight, blindness
* insufficient German language skills
* no informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01600404
Study Brief:
Protocol Section:
NCT01600404