Hydrocephalus Clinical Trial
Official title:
The Role of Neurofilament Light (NfL) in Management of Patients With Hydrocephalus: A Pilot Study
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Hradec Kralove | Hradec Králové |
Lead Sponsor | Collaborator |
---|---|
University Hospital Hradec Kralove |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Influence of general anesthesia on the level of NfL | In group B investigate the level of NfL 24 hours before surgery and 24 hours (blood sampling #2) and 5 days after surgery (blood sampling #3) and comparison with standardized NfL level based on literature. Looking for the influence of general anesthesia on brain damage caused and the prepair in predefined time frame. | 24 hours before procedure (surgery) and 24 hours and 5 days after surgery | |
Primary | Recruitment rate | To assess the number of patients recruited in a pilot study. Recruitment rate is one of the predictor of feasibility of a study | 6 months | |
Primary | Number of changes in valve settings | To investigate the number of changes in valve settings according the patient's clinical state based on clinical examination, CT examination or telemetrically measured CSF pressure | 3 months after surgery | |
Secondary | Correlation between NfL level and patient's clinical state | To investigate in group A the correlation between the level of NfL get from CSF and blood sampling and observation in changes in patient's clinical state measured by mini-mental state examination (MMSE), 5-meter-walking test and patient's self-assessment questionare | 3 months after surgery |
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