Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-11 @ 8:01 PM
Study NCT ID:
NCT05399602
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2022-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006849', 'term': 'Hydrocephalus'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'C537987', 'term': 'Charcot-Marie-Tooth disease, Type 1F'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013129', 'term': 'Spinal Puncture'}, {'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-27', 'studyFirstSubmitDate': '2022-05-26', 'studyFirstSubmitQcDate': '2022-05-26', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Influence of general anesthesia on the level of NfL', 'timeFrame': '24 hours before procedure (surgery) and 24 hours and 5 days after surgery', '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.'}], 'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': '6 months', 'description': 'To assess the number of patients recruited in a pilot study. Recruitment rate is one of the predictor of feasibility of a study'}, {'measure': 'Number of changes in valve settings', 'timeFrame': '3 months after surgery', '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"}], 'secondaryOutcomes': [{'measure': "Correlation between NfL level and patient's clinical state", 'timeFrame': '3 months after surgery', '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"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hydrocephalus', 'Brain biomarkers', 'Neurofilament Light Chain', 'General Anesthesia'], 'conditions': ['Hydrocephalus', 'Brain Damage', 'General Anesthetics Toxicity']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In group A:\n\n * Patients with diagnosed communicating hydrocephalus\n * MMSE \\> 10 points\n * Absence of any structural laesion on MRI or CT\n * Accepted Informed consent\n* In group B:\n\n * MMSE \\> 10 points\n * Absence of any structural laesion on MRI or CT\n * Accepted Informed consent\n * Elective spinal surgery without affecting dural sac and the spinal cord\n * Surgery shorter than 120 minutes of lasting the general anesthesia\n\nExclusion Criteria:\n\n* Non-communicating hydrocephalus\n* Structural laesion on MRI or CT (tumour, contusion, aneurysm)\n* MMSE \\< 10 points\n* Life-expectancy shorter than 1 year\n* Pre-existing other type of demetia (m. Alzheimer, vascular dementia)\n* Surgery lasting more than 120 minutes\n* Blood loss more than 500 ml\n* Opening of dural sac (liquororhea)\n* Adverse events during general anestesia: MAP\\<60 mm Hg more than 5 minutes, arythmia with need for farmacological treatment'}, 'identificationModule': {'nctId': 'NCT05399602', 'briefTitle': 'The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Hradec Kralove'}, 'officialTitle': 'The Role of Neurofilament Light (NfL) in Management of Patients With Hydrocephalus: A Pilot Study', 'orgStudyIdInfo': {'id': 'MC00000001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '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.', 'interventionNames': ['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']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Study group B', '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.', 'interventionNames': ['Procedure: General Anesthesia', 'Procedure: Blood sampling #1', 'Procedure: Blood sampling #2', 'Procedure: Blood sampling #3']}], 'interventions': [{'name': 'Lumbar puncture', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and CSF sampling (sample 1 in NfL level measurement)', 'armGroupLabels': ['Study group A']}, {'name': 'External lumbar drainage', 'type': 'DIAGNOSTIC_TEST', 'description': 'External lumbar drainage placement for assessing responsivity of external derivation of CSF. It is test of responsivity to ventriculo-peritoneal shunt placement', 'armGroupLabels': ['Study group A']}, {'name': 'Lumbar infusion test', 'type': 'DIAGNOSTIC_TEST', '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).', 'armGroupLabels': ['Study group A']}, {'name': 'Ventriculo-peritoneal shunt placement', 'type': 'PROCEDURE', '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).', 'armGroupLabels': ['Study group A']}, {'name': 'General Anesthesia', 'type': 'PROCEDURE', 'description': 'Standardized combinated general anesthesia with combination of i.v. and inhalated drugs according the protocol. Given by anesthesiologist.', 'armGroupLabels': ['Study group A', 'Study group B']}, {'name': 'Prechamber puncture', 'type': 'PROCEDURE', '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)', 'armGroupLabels': ['Study group A']}, {'name': 'Blood sampling #1', 'type': 'PROCEDURE', 'description': 'Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours prior surgery', 'armGroupLabels': ['Study group A', 'Study group B']}, {'name': 'Blood sampling #2', 'type': 'PROCEDURE', 'description': 'Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours after surgery', 'armGroupLabels': ['Study group A', 'Study group B']}, {'name': 'Blood sampling #3', 'type': 'PROCEDURE', 'description': 'Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 5 days after surgery', 'armGroupLabels': ['Study group A', 'Study group B']}, {'name': 'Blood sampling #4 and #5', 'type': 'PROCEDURE', '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)', 'armGroupLabels': ['Study group A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50005', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'University Hospital Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}], 'overallOfficials': [{'name': 'Miroslav Cihlo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Hradec Kralove'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Hradec Kralove', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Miroslav Cihlo', 'investigatorAffiliation': 'University Hospital Hradec Kralove'}}}}