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

University Hospital Hradec Kralove

Status: Completed

Conditions: Hydrocephalus; Brain Damage; General Anesthetics Toxicity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05399602

MC00000001

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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41 participants in 2 patient groups

Study group A

Experimental group

Description:

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.

Treatment:

Procedure: Ventriculo-peritoneal shunt placement

Procedure: Blood sampling #3

Diagnostic Test: Lumbar puncture

Procedure: General Anesthesia

Diagnostic Test: External lumbar drainage

Procedure: Blood sampling #1

Procedure: Prechamber puncture

Procedure: Blood sampling #2

Diagnostic Test: Lumbar infusion test

Procedure: Blood sampling #4 and #5

Study group B

Active Comparator group

Description:

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.

Treatment:

Procedure: Blood sampling #3

Procedure: General Anesthesia

Procedure: Blood sampling #1

Procedure: Blood sampling #2