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

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

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)

Sponsors & Collaborators

• University Hospital Hradec Kralove

  lead OTHER

Principal Investigators

• Miroslav Cihlo, M.D. · University Hospital Hradec Kralove

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-07

Primary Completion

2025-09-27

Completion

2025-09-27

Countries

• Czechia

Study Locations