Skip to main content
OpenTrials
Completed

NCT Number: NCT05399602

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hydrocephalus Brain Damage Brain Diseases Brain Injuries Central Nervous System Diseases Charcot-Marie-Tooth disease, Type 1F Craniocerebral Trauma General Anesthetics Toxicity Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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

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)

Primary outcomes

  1. Recruitment rate

    Time frame: 6 months

    To assess the number of patients recruited in a pilot study. Recruitment rate is one of the predictor of feasibility of a study

  2. Number of changes in valve settings

    Time frame: 3 months after surgery

    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

Secondary outcomes

  1. Correlation between NfL level and patient's clinical state

    Time frame: 3 months after surgery

    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

Other outcomes

  1. Influence of general anesthesia on the level of NfL

    Time frame: 24 hours before procedure (surgery) and 24 hours and 5 days after surgery

    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.

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 1, 2022
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.