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

Not Applicable

Recruiting

• Conditions: Hydrocephalus; General Anesthetics Toxicity; Brain Damage
• Interventions: Diagnostic Test: Lumbar puncture; Diagnostic Test: External lumbar drainage; Diagnostic Test: Lumbar infusion test; Procedure: Ventriculo-peritoneal shunt placement; Procedure: Blood sampling #3; Procedure: General Anesthesia; Procedure: Prechamber puncture; Procedure: Blood sampling #1; Procedure: Blood sampling #2; Procedure: Blood sampling #4 and #5

• Registration Number: NCT05399602
• Lead Sponsor: University Hospital Hradec Kralove

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-06-01
• Study Start: 2023-12-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group A	General Anesthesia	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.
Study group A	Prechamber puncture	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.
Study group A	Blood sampling #2	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.
Study group B	General Anesthesia	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.
Study group A	Lumbar puncture	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.
Study group A	External lumbar drainage	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.
Study group A	Lumbar infusion test	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.
Study group A	Ventriculo-peritoneal shunt placement	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.
Study group B	Blood sampling #3	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.
Study group A	Blood sampling #1	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.
Study group A	Blood sampling #3	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.
Study group B	Blood sampling #1	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.
Study group B	Blood sampling #2	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.
Study group A	Blood sampling #4 and #5	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.

Primary Outcome Measures

Name	Time	Method
Number of changes in valve settings	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
Recruitment rate	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

Secondary Outcome Measures

Name	Time	Method
Correlation between NfL level and patient's clinical state	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

Trial Locations

Locations (1)

University Hospital Hradec Kralove; 🇨🇿 Hradec Králové, Czechia