The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus
NCT ID: NCT05399602
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2023-12-07
2025-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Study group A
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.
Lumbar puncture
Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and CSF sampling (sample 1 in NfL level measurement)
External lumbar drainage
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 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
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
Standardized combinated general anesthesia with combination of i.v. and inhalated drugs according the protocol. Given by anesthesiologist.
Prechamber puncture
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
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours prior surgery
Blood sampling #2
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours after surgery
Blood sampling #3
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 5 days after surgery
Blood sampling #4 and #5
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)
Study group B
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.
General Anesthesia
Standardized combinated general anesthesia with combination of i.v. and inhalated drugs according the protocol. Given by anesthesiologist.
Blood sampling #1
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours prior surgery
Blood sampling #2
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours after surgery
Blood sampling #3
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 5 days after surgery
Interventions
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Lumbar puncture
Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and CSF sampling (sample 1 in NfL level measurement)
External lumbar drainage
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 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
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
Standardized combinated general anesthesia with combination of i.v. and inhalated drugs according the protocol. Given by anesthesiologist.
Prechamber puncture
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
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours prior surgery
Blood sampling #2
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours after surgery
Blood sampling #3
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 5 days after surgery
Blood sampling #4 and #5
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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University Hospital Hradec Kralove
OTHER
Responsible Party
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Miroslav Cihlo
Principal investigator
Principal Investigators
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Miroslav Cihlo, M.D.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Hradec Kralove
Locations
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University Hospital Hradec Kralove
Hradec Králové, , Czechia
Countries
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Other Identifiers
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MC00000001
Identifier Type: -
Identifier Source: org_study_id
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