The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus (NCT05399602) | Clinical Trial Compass
CompletedNot Applicable
The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus
Czechia41 participantsStarted 2023-12-07
Plain-language summary
Neurofilament Light Chain Protein (NfL) has been found by many studies as a sensitive biomarker of neuronal damage from several reasons, e.g. neurodegenerative diseases (Alzheimer's disease, Multiple Sclerosis, etc.), inflamation (HIV) or trauma. Its role as biomarker thus offers a possibility to predict and manage diseases associated with neuronal damage. Therefore our aim is to investigate the changes in level of NfL in hydrocephalus and to find its role in management of treatment in hydrocephalus.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.