Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-25 @ 5:55 PM
Study NCT ID:
NCT06629168
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2024-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Usage of Telemetric Prechamber Sensor Reservoir in Management of Normal Pressure Hydrocephalus. Comparisson of Benefit for Patients with Implanted Telemetric Prechamber Sensor Reservoir.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006849', 'term': 'Hydrocephalus'}, {'id': 'D006850', 'term': 'Hydrocephalus, Normal Pressure'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013129', 'term': 'Spinal Puncture'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2024-10-04', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Comparison of patient's state", 'timeFrame': '3 month', 'description': 'Comparison of mini-mental state examination, gait (measured by 5-meter-walking) test a self-assessment made by patient between both group (telemetric prechamber impanted versus not implanted)'}], 'secondaryOutcomes': [{'measure': 'Comparison in radiological findings', 'timeFrame': '1 year', 'description': 'Comparison of size of brain ventricles on brain CT examination at the end of follow-up between both groups'}, {'measure': 'Comparison in number of valve setting', 'timeFrame': '1 year', 'description': 'Comparison in number of valve setting between both groups'}, {'measure': 'Comparison of difference in valve settings', 'timeFrame': '1 year', 'description': 'Comparison of difference in valve settings - between pressure set in time of implantation and at the end of follow up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Normal pressure hydrocephalus', 'VP drainage', 'telemetry', 'pressure monitoring'], 'conditions': ['Hydrocephalus', 'Normal Pressure Hydrocephalus', 'Normal Pressure Hydrocephalus Patients']}, 'descriptionModule': {'briefSummary': 'Normal pressure hydrocephalus (NPH) is a preventable and treatable cause of dementia. However, as a nosological entity, it is significantly underdiagnosed, often being mistakenly classified as presenile or senile dementia without further investigation. Ongoing management is crucial, currently relying mainly on indirect methods-clinical and imaging-based. Telemetry offers a real-time, online method to assess actual cerebrospinal fluid pressures, which are crucial for patient management. Telemetry allows for tailoring treatment to the individual patient. This project is planned as a pilot study before a more extensive research project.', 'detailedDescription': 'Normal pressure hydrocephalus (NPH) is a preventable and treatable cause of dementia. However, as a nosological entity, it is significantly underdiagnosed, often being mistakenly classified as presenile or senile dementia without further investigation. Diagnosing NPH is not straightforward; it is based on a series of examinations, the results of which determine whether the patient is a responder and therefore a candidate for shunt surgery (implantation of a ventriculoperitoneal shunt). The medical literature identifies additional criteria that predict whether the implantation of the shunt will have a good or poor effect. However, treatment from a neurosurgical perspective does not end there. Ongoing management is crucial, currently relying mainly on indirect methods-clinical and imaging-based. Telemetry offers a real-time, online method to assess actual cerebrospinal fluid pressures, which are crucial for patient management. Telemetry allows for tailoring treatment to the individual patient. This project is planned as a pilot study before a more extensive research project.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients selected based on inclusion criterias, with communicating hydrocephalus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosed communicating hydrocephalus\n* mini-mental state examination test \\> 10 points\n* Absence of any structural lesion on MRI or CT\n* Accepted Informed consent\n\nExclusion Criteria:\n\n* Non-communicating hydrocephalus\n* Structural lesion on MRI or CT (tumour, contusion, aneurysm)\n* mini-mental state examination test \\< 10 points\n* Life-expectancy shorter than 1 year\n* Pre-existing other type of dementia (m. Alzheimer, vascular dementia)\n* Surgery lasting more than 120 minutes\n* Blood loss more than 500 ml\n* Adverse events during general anesthesia: mean arterial pressure \\< 60 mm Hg more than 5 minutes, arrythmia with need for pharmacological treatment'}, 'identificationModule': {'nctId': 'NCT06629168', 'briefTitle': 'The Usage of Telemetric Prechamber Sensor Reservoir in Management of Normal Pressure Hydrocephalus. Comparisson of Benefit for Patients with Implanted Telemetric Prechamber Sensor Reservoir.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Hradec Kralove'}, 'officialTitle': 'Usage of Telemetric Prechamber Sensor Reservoir in Management of Hydrocephalus', 'orgStudyIdInfo': {'id': 'MC00003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group "Telemetrics"', 'description': 'Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber implantad.', 'interventionNames': ['Diagnostic Test: lumbar puncture', 'Diagnostic Test: External lumbar drainage', 'Procedure: Ventriculo-peritoneal shunt placement', 'Diagnostic Test: Follow-up control #1', 'Diagnostic Test: Follow-up control #2', 'Diagnostic Test: Follow-up control #3', 'Diagnostic Test: Follow-up control #4', 'Diagnostic Test: Telemetric prechamber reading', 'Other: Valve setting change']}, {'label': 'Study group "Normal"', 'description': 'Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber not implantad.', 'interventionNames': ['Diagnostic Test: lumbar puncture', 'Diagnostic Test: External lumbar drainage', 'Procedure: Ventriculo-peritoneal shunt placement', 'Diagnostic Test: Follow-up control #1', 'Diagnostic Test: Follow-up control #2', 'Diagnostic Test: Follow-up control #3', 'Diagnostic Test: Follow-up control #4', 'Other: Valve setting change']}], 'interventions': [{'name': 'lumbar puncture', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and 10-meter-walking test prior and 4 hours after lumbar puncture. Mini-mental state examination is done.', 'armGroupLabels': ['Study group "Normal"', 'Study group "Telemetrics"']}, {'name': 'External lumbar drainage', 'type': 'DIAGNOSTIC_TEST', 'description': 'External lumbar drainage placement for assessing responsivity of external derivation of cerebrospinal fluid. It is test of responsivity to ventriculo-peritoneal shunt placement', 'armGroupLabels': ['Study group "Normal"', 'Study group "Telemetrics"']}, {'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). Telemetric prechamber placement according the randomization (www.randomization.com) and the envelope method of choosing of patients.', 'armGroupLabels': ['Study group "Normal"', 'Study group "Telemetrics"']}, {'name': 'Follow-up control #1', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 3 month after surgery. Brain CT control.', 'armGroupLabels': ['Study group "Normal"', 'Study group "Telemetrics"']}, {'name': 'Follow-up control #2', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 6 month after surgery. Brain CT control.', 'armGroupLabels': ['Study group "Normal"', 'Study group "Telemetrics"']}, {'name': 'Follow-up control #3', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 9 months after surgery. Brain CT control.', 'armGroupLabels': ['Study group "Normal"', 'Study group "Telemetrics"']}, {'name': 'Follow-up control #4', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score a month after surgery. Brain CT control, 10-meter-walking test, MMSE, self-assessment.', 'armGroupLabels': ['Study group "Normal"', 'Study group "Telemetrics"']}, {'name': 'Telemetric prechamber reading', 'type': 'DIAGNOSTIC_TEST', 'description': 'Non-invasive reading of telemetric prechamber made during each follow-up control.', 'armGroupLabels': ['Study group "Telemetrics"']}, {'name': 'Valve setting change', 'type': 'OTHER', 'description': "Changing of valve setting according patient's actual condition. Decission based on clinical state, radiological finding on CT and values readed from telemetric prechamber. Timing - each follow-up control.", 'armGroupLabels': ['Study group "Normal"', 'Study group "Telemetrics"']}]}, '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'}}}}