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

Learn more about:
Related Clinical Trial
Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar Assessment of CSF Shunt Flow With Thermal Measurements B The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus: A Pilot Study Quantitative Pupillometry Pilot Study to Evaluate the CereVasc® eShunt® System US Pilot Study to Evaluate the CereVasc® eShunt® System Prediction Model of Improvement of Disturbance of Consciousness in Patients With Hydrocephalus After Shunt Operation Combined Flow and Pressure Study of Craniospinal Dynamic Assessment of CSF Shunt Flow With Thermal Measurements Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)? Brain Aneurysms: Utility of Cisternal Urokinase Irrigation Three-step Disinfection Reduce the Postoperative Infection Rate of Ventriculoperitoneal Shunt Endoscopic Third Ventriculostomy for Adults: A Prognostic Model for Success The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt) Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ? Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients’ Treatment Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage Bactiseal Catheter Safety Registry in China Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement Hyperfine Portable MRI in Hydrocephalus Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries An Evaluation of a Non-invasive Brain Monitor An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device Assess Specific Kinds of Children Challenges for Neurologic Devices Study A Secondary Study Evaluating Aqueduct’s Smart External Drain (SED) Simulation Efficacy in Neurosurgical Education Intraoral 30% Glucose Effect In Newborns The Prediction of Intracranial Pressure and Clinical Outcome by Transcranial Doppler in Neurocritical Patients Impact of Ventricular Catheter Used With Antimicrobial Agents on Patients With a Ventricular Catheter Subgaleal Drains in Decompressive Craniectomies Role of Proteomics and Metallomics in Cerebral Vasospasm Following Subarachnoid Hemorrhage A Study Evaluate Aqueduct’s Smart External Drain Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH) Optimizing Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters Study of Ultrasound of the Eye for Children With Suspected Shunt Failure MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics Tablet-guided Versus Freehand (Tab-Guide) Ventriculostomy : Study Protocol to the Test Accuracy of Ventriculostomy in a Randomized Controlled Trial Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System. Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage Brain Ultrasound in the Weaning of External Ventricular Leads A Study on the Safety of Hakim Programmable Shunt System Thermal Camera Detection of Ventriculoperitoneal Shunt Flow Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique Bench Study of Transcutaneous Hydrocephalic Shunt Flow Sensor Alignment Accuracy and Repeatability NIMIP: Non Invasive Measurement of the Intracranial Pressure Linking Digital Smartphone Behaviour With Brain Function Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains. Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement–Celda Infusion Subprotocol Strata Programmable CSF Shunt Valve Study The CSF Shunt Entry Site Trial Guided Application of Ventricular Catheters Value of MRI CSF Flowmetry in Assessment of Grey Zone Hydrocephalic Patients Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor Comparison of Optic Nerve Sheath Diameter Measured by Ultrasonography Before and After Ventriculoperitoneal Shunt Surgery in Adult Patients With Hydrocephalus CRT ShuntCheck “Fit & Function” Study Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk NIRS Monitoring in Premature Infants Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasound Before and After Drainage of Cerebrospinal Fluid in Patient With Hydrocephalus Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasonography Before and After Drainage of Cerebrospinal Fluid in Pediatric Patient With Hydrocephalus ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients Isoflurane-induced Neuroinflammation in Children With Hydrocephalus Hydrocephalus iPad-App Based Intervention Study Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus A Study Comparing Two Treatments for Infants With Hydrocephalus A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus Efficacy Study of Hydrocephalus Surgery by Methods of Neuroelectrophysiology Study of Choroid Plexus Cauderization in Patients With Hydrocephalus ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus BIS Monitoring of Patients With Hydrocephalus Magnetic Resonance Elastography in Hydrocephalus Noninvasive Intracranial Pressure and Hydrocephalus Patients Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

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

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.
    



Study Type

Interventional


Primary Outcome

Recruitment rate

Secondary Outcome

 Correlation between NfL level and patient's clinical state

Condition

Hydrocephalus

Intervention

Lumbar puncture

Study Arms / Comparison Groups

 Study group A
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

20

Start Date

June 1, 2022

Completion Date

May 31, 2023

Primary Completion Date

December 31, 2022

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
      

Gender

All

Ages

50 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Miroslav Cihlo, M.D., +420495832550, [email protected]



Administrative Informations


NCT ID

NCT05399602

Organization ID

MC00000001


Responsible Party

Principal Investigator

Study Sponsor

University Hospital Hradec Kralove


Study Sponsor

Miroslav Cihlo, M.D., Principal Investigator, University Hospital Hradec Kralove


Verification Date

June 2022