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:
NCT05399602
Eligibility Criteria:
Inclusion Criteria:
* In group A:
* Patients with diagnosed communicating hydrocephalus
* MMSE \> 10 points
* Absence of any structural laesion on MRI or CT
* Accepted Informed consent
* In group B:
* MMSE \> 10 points
* Absence of any structural laesion on MRI or CT
* Accepted Informed consent
* Elective spinal surgery without affecting dural sac and the spinal cord
* Surgery shorter than 120 minutes of lasting the general anesthesia
Exclusion Criteria:
* Non-communicating hydrocephalus
* Structural laesion on MRI or CT (tumour, contusion, aneurysm)
* MMSE \< 10 points
* Life-expectancy shorter than 1 year
* Pre-existing other type of demetia (m. Alzheimer, vascular dementia)
* Surgery lasting more than 120 minutes
* Blood loss more than 500 ml
* Opening of dural sac (liquororhea)
* Adverse events during general anestesia: MAP\<60 mm Hg more than 5 minutes, arythmia with need for farmacological treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT05399602
Study Brief:
Protocol Section:
NCT05399602