HydrocephalusNCT05399602
The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus
A study testing Lumbar puncture, External lumbar drainage and Lumbar infusion test in people with Hydrocephalus and Brain Damage, run by University Hospital Hradec Kralove at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hydrocephalus, Brain Damage, General Anesthetics Toxicity
- What is being tested?
- Lumbar puncture, External lumbar drainage and Lumbar infusion test
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCzechia
- Study dates
- 7 Dec 2023to 27 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hydrocephalus, Brain Damage, General Anesthetics Toxicity
- Being tested
- Lumbar puncture, External lumbar drainage, Lumbar infusion test, Ventriculo-peritoneal shunt placement, General Anesthesia
- Keywords
- Hydrocephalus, Brain biomarkers, Neurofilament Light Chain, General Anesthesia
- Medical subject headings
- Hydrocephalus, Brain Injuries, Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar punctureDiagnostic test
Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and CSF sampling (sample 1 in NfL level measurement)
External lumbar drainageDiagnostic test
External lumbar drainage placement for assessing responsivity of external derivation of CSF. It is test of responsivity to ventriculo-peritoneal shunt placement
Lumbar infusion testDiagnostic 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).
Ventriculo-peritoneal shunt placementProcedure or surgery
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 AnesthesiaProcedure or surgery
Standardized combinated general anesthesia with combination of i.v. and inhalated drugs according the protocol. Given by anesthesiologist.
Prechamber punctureProcedure or surgery
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 #1Procedure or surgery
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours prior surgery
Blood sampling #2Procedure or surgery
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours after surgery
Blood sampling #3Procedure or surgery
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 5 days after surgery
Blood sampling #4 and #5Procedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Study group A | Experimental | 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. Receives: Diagnostic Test: Lumbar puncture; Diagnostic Test: External lumbar drainage; Diagnostic Test: Lumbar infusion test; Procedure: Ventriculo-peritoneal shunt placement; Procedure: General Anesthesia; Procedure: Prechamber puncture; Procedure: Blood sampling #1; Procedure: Blood sampling #2; Procedure: Blood sampling #3; Procedure: Blood sampling #4 and #5 |
| Study group B | Active comparator | 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. Receives: Procedure: General Anesthesia; Procedure: Blood sampling #1; Procedure: Blood sampling #2; Procedure: Blood sampling #3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
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
Measured: 3 months after surgery
Secondary outcomes (1)
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
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start7 Dec 2023
- Primary completion27 Sep 2025
- Study completion27 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miroslav Cihlo, University Hospital Hradec Kralove
- Investigators
- Miroslav Cihlo, M.D., Principal investigator, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399602
- Sponsor's protocol ID
- MC00000001
- Status last verified
- Sep 2025
- First submitted
- 26 May 2022
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Neurofilament Light (NfL) in Management of Patients With Hydrocephalus: A Pilot Study
- ClinicalTrials.gov ID
- NCT05399602
- Acronym / sponsor ID
- MC00000001
- Conditions
- Hydrocephalus, Brain Damage, General Anesthetics Toxicity
- Keywords
- Hydrocephalus, Brain biomarkers, Neurofilament Light Chain, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 27 Sep 2025 (actual)
- Study completion
- 27 Sep 2025 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group A | Experimental | Diagnostic Test: Lumbar puncture, Diagnostic Test: External lumbar drainage, Diagnostic Test: Lumbar infusion test, Procedure: Ventriculo-peritoneal shunt placement, Procedure: General Anesthesia, Procedure: Prechamber puncture, Procedure: Blood sampling #1, Procedure: Blood sampling #2, Procedure: Blood sampling #3, Procedure: Blood sampling #4 and #5Patients 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 | Active comparator | Procedure: General Anesthesia, Procedure: Blood sampling #1, Procedure: Blood sampling #2, Procedure: Blood sampling #3Patients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- In group A:
- In group B:
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar punctureStandardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and CSF sampling (sample 1 in NfL level measurement) | Diagnostic test | Study group A |
| External lumbar drainageExternal lumbar drainage placement for assessing responsivity of external derivation of CSF. It is test of responsivity to ventriculo-peritoneal shunt placement | Diagnostic test | Study group A |
| Lumbar infusion testDiagnostic 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). | Diagnostic test | Study group A |
| Ventriculo-peritoneal shunt placementSurgical 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 or surgery | Study group A |
| General AnesthesiaStandardized combinated general anesthesia with combination of i.v. and inhalated drugs according the protocol. Given by anesthesiologist. | Procedure or surgery | Study group A, Study group B |
| Prechamber puncturePuncture 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 or surgery | Study group A |
| Blood sampling #1Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours prior surgery | Procedure or surgery | Study group A, Study group B |
| Blood sampling #2Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours after surgery | Procedure or surgery | Study group A, Study group B |
| Blood sampling #3Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 5 days after surgery | Procedure or surgery | Study group A, Study group B |
| Blood sampling #4 and #5Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 1 and 2 months after surgery (only in interventional group) | Procedure or surgery | Study group A |
Primary outcome
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
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
1 secondary outcome
Correlation between NfL level and patient's clinical state
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miroslav Cihlo, M.D. principal investigator
University Hospital Hradec Kralove
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar puncture, External lumbar drainage and Lumbar infusion test in people with Hydrocephalus and Brain Damage, run by University Hospital Hradec Kralove at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.