Back to resultsThe Role of Neurofilament Light (NfL) in Patients With Hydrocephalus
Primary Purpose
Hydrocephalus, Brain Damage, General Anesthetics Toxicity
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Lumbar puncture
External lumbar drainage
Lumbar infusion test
Ventriculo-peritoneal shunt placement
General Anesthesia
Prechamber puncture
Blood sampling #1
Blood sampling #2
Blood sampling #3
Blood sampling #4 and #5
Sponsored by
About this trial
This is an interventional treatment trial for Hydrocephalus focused on measuring Hydrocephalus, Brain biomarkers, Neurofilament Light Chain, General Anesthesia
Eligibility Criteria
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
Sites / Locations
- University Hospital Hradec KraloveRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group A
Study group B
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05399602
First Posted
May 26, 2022
Last Updated
October 8, 2023
Sponsor
University Hospital Hradec Kralove
1. Study Identification
Unique Protocol Identification Number
NCT05399602
Brief Title
The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus
Official Title
The Role of Neurofilament Light (NfL) in Management of Patients With Hydrocephalus: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Hradec Kralove
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrocephalus, Brain Damage, General Anesthetics Toxicity
Keywords
Hydrocephalus, Brain biomarkers, Neurofilament Light Chain, General Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group A
Arm Type
Experimental
Arm 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.
Arm Title
Study group B
Arm Type
Active Comparator
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Lumbar puncture
Intervention Description
Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and CSF sampling (sample 1 in NfL level measurement)
Intervention Type
Diagnostic Test
Intervention Name(s)
External lumbar drainage
Intervention Description
External lumbar drainage placement for assessing responsivity of external derivation of CSF. It is test of responsivity to ventriculo-peritoneal shunt placement
Intervention Type
Diagnostic Test
Intervention Name(s)
Lumbar infusion test
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Ventriculo-peritoneal shunt placement
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
General Anesthesia
Intervention Description
Standardized combinated general anesthesia with combination of i.v. and inhalated drugs according the protocol. Given by anesthesiologist.
Intervention Type
Procedure
Intervention Name(s)
Prechamber puncture
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Blood sampling #1
Intervention Description
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours prior surgery
Intervention Type
Procedure
Intervention Name(s)
Blood sampling #2
Intervention Description
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours after surgery
Intervention Type
Procedure
Intervention Name(s)
Blood sampling #3
Intervention Description
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 5 days after surgery
Intervention Type
Procedure
Intervention Name(s)
Blood sampling #4 and #5
Intervention Description
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)
Primary Outcome Measure Information:
Title
Recruitment rate
Description
To assess the number of patients recruited in a pilot study. Recruitment rate is one of the predictor of feasibility of a study
Time Frame
6 months
Title
Number of changes in valve settings
Description
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
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Correlation between NfL level and patient's clinical state
Description
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
Time Frame
3 months after surgery
Other Pre-specified Outcome Measures:
Title
Influence of general anesthesia on the level of NfL
Description
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.
Time Frame
24 hours before procedure (surgery) and 24 hours and 5 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miroslav Cihlo, M.D.
Phone
+420495832550
Email
miroslav.cihlo@fnhk.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miroslav Cihlo, M.D.
Organizational Affiliation
University Hospital Hradec Kralove
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Hradec Kralove
City
Hradec Králové
ZIP/Postal Code
50005
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miroslav Cihlo, M.D.
Phone
+420495832550
Email
miroslav.cihlo@fnhk.cz
12. IPD Sharing Statement
Learn more about this trial
The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus
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