NCT05399602

The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus

The Role of Neurofilament Light (NfL) in Management of Patients With Hydrocephalus: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University Hospital Hradec Kralove · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hydrocephalus
• Brain Damage
• General Anesthetics Toxicity

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Lumbar puncture	Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and CSF sampling (sample 1 in NfL level measurement)
DIAGNOSTIC_TEST	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
DIAGNOSTIC_TEST	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).
PROCEDURE	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).
PROCEDURE	General Anesthesia	Standardized combinated general anesthesia with combination of i.v. and inhalated drugs according the protocol. Given by anesthesiologist.
PROCEDURE	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)
PROCEDURE	Blood sampling #1	Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours prior surgery
PROCEDURE	Blood sampling #2	Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours after surgery
PROCEDURE	Blood sampling #3	Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 5 days after surgery
PROCEDURE	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)

Timeline

• Start date: 2023-12-07
• Primary completion: 2025-09-27
• Completion: 2025-09-27
• First posted: 2022-06-01
• Last updated: 2025-10-02

Locations

1 site across 1 country: Czechia