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

Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05399602
• Other study ID #: MC00000001
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University Hospital Hradec Kralove
• Contact: Miroslav Cihlo, M.D.
• Phone: +420495832550
• Email: miroslav.cihlo[@]fnhk.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Damage
• Brain Injuries
• General Anesthetics Toxicity
• Hydrocephalus

Intervention

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)
• 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
• 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).
• General Anesthesia
Standardized combinated general anesthesia with combination of i.v. and inhalated drugs according the protocol. Given by anesthesiologist.
• 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)
• Blood sampling #1
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours prior surgery
• Blood sampling #2
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours after surgery
• Blood sampling #3
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 5 days after surgery
• 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)

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Kralove	Hradec Králové

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Influence of general anesthesia on the level of NfL	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
Primary	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
Primary	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	Correlation between NfL level and patient's clinical state	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