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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group A | Experimental | Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anestezia. Before surgery patients undergo lumbar puncture or external lumbar drainage placement to confirmate the diagnosis and responsivity to VP shunt placement. |
|
| Study group B | Active Comparator | Patients without diagnosed hydrocephalus undergoing short spinal surgery without affecting dural sac (e.g. anterior cervical discectomy and fusion or lumbar disc herniation or lumbar decompression) in general anestezia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar puncture | Diagnostic Test | Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and CSF sampling (sample 1 in NfL level measurement) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
In group A:
In group B:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miroslav Cihlo, M.D. | University Hospital Hradec Kralove | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hradec Kralove | Hradec Králové | 50005 | Czechia |
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| External lumbar drainage | Diagnostic Test | External lumbar drainage placement for assessing responsivity of external derivation of CSF. It is test of responsivity to ventriculo-peritoneal shunt placement |
|
| Lumbar infusion test | Diagnostic Test | Diagnostic test accompanying the first lumbar puncture made as i diagnostic test of hydrocephalus. Based on infusion of saline by 90 mL per hour with measurement of CSF pressure each 1 minute and then count of so-called Rout (index). |
|
| Ventriculo-peritoneal shunt placement | Procedure | Surgical procedure based on implantation a thin catheter into brain lateral ventricle (placed through a burrhole from Kocher point) and connection to prechamber and valve (placed behind the ear under skin) and similar thin catheter pushed under skin of neck, chest and abdomen (where put intraperitoneally). |
|
| General Anesthesia | Procedure | Standardized combinated general anesthesia with combination of i.v. and inhalated drugs according the protocol. Given by anesthesiologist. |
|
| Prechamber puncture | Procedure | Puncture of prechamber (place behind the ear under the skin) by thin needle and aspiration of 5 mL of CSF (5 days, 1 month a 2 months after surgery) |
|
| Blood sampling #1 | Procedure | Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours prior surgery |
|
| Blood sampling #2 | Procedure | Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours after surgery |
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| Blood sampling #3 | Procedure | Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 5 days after surgery |
|
| Blood sampling #4 and #5 | Procedure | Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 1 and 2 months after surgery (only in interventional group) |
|
| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| D001930 | Brain Injuries |
| C537987 | Charcot-Marie-Tooth disease, Type 1F |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D013129 | Spinal Puncture |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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