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

May 8, 2024 updated by: Miroslav Cihlo, University Hospital Hradec Kralove

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Hradec Králové, Czechia, 50005
        • Recruiting
        • University Hospital Hradec Kralove
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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)
Active Comparator: 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.
Procedure: General Anesthesia
Standardized combinated general anesthesia with combination of i.v. and inhalated drugs according the protocol. Given by anesthesiologist.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours before procedure (surgery) and 24 hours and 5 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Hradec Kralove

Investigators

  • Principal Investigator: Miroslav Cihlo, M.D., University Hospital Hradec Kralove

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2023

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC00000001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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