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

NCT05399602 | Completed

• 1 other identifier: MC00000001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hydrocephalus; Brain biomarkers; Neurofilament Light Chain; General Anesthesia

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Correlation between NfL level and patient's clinical state

  3 months after surgery

Other Outcomes (1)

• Influence of general anesthesia on the level of NfL

  24 hours before procedure (surgery) and 24 hours and 5 days after surgery

Study Arms (2)

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.

Diagnostic Test: Lumbar puncture; Diagnostic Test: External lumbar drainage; Diagnostic Test: Lumbar infusion test; Procedure: Ventriculo-peritoneal shunt placement; Procedure: General Anesthesia; Procedure: Prechamber puncture; Procedure: Blood sampling #1; Procedure: Blood sampling #2; Procedure: Blood sampling #3; Procedure: Blood sampling #4 and #5

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.

Procedure: General Anesthesia; Procedure: Blood sampling #1; Procedure: Blood sampling #2; Procedure: Blood sampling #3

Interventions

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)

Study group A

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

Study group A

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).

Study group A

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).

Study group A

General Anesthesia PROCEDURE

Standardized combinated general anesthesia with combination of i.v. and inhalated drugs according the protocol. Given by anesthesiologist.

Study group A; Study group B

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)

Study group A

Blood sampling #1 PROCEDURE

Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours prior surgery

Study group A; Study group B

Blood sampling #2 PROCEDURE

Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours after surgery

Study group A; Study group B

Blood sampling #3 PROCEDURE

Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 5 days after surgery

Study group A; Study group B

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)

Study group A

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

MeSH Terms

Conditions

Hydrocephalus; Brain Injuries; Charcot-Marie-Tooth disease, Type 1F

Interventions

Spinal Puncture; Anesthesia, General

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Anesthesia; Anesthesia and Analgesia

Study Officials

• Miroslav Cihlo, M.D.

  University Hospital Hradec Kralove

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: December 7, 2023
• Primary Completion: September 27, 2025
• Study Completion: September 27, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

CZ (1)