The Usage of Telemetric Prechamber Sensor Reservoir in Management of Normal Pressure Hydrocephalus. Comparisson of Benefit for Patients with Implanted Telemetric Prechamber Sensor Reservoir.
- Conditions
- HydrocephalusNormal Pressure HydrocephalusNormal Pressure Hydrocephalus Patients
- Registration Number
- NCT06629168
- Lead Sponsor
- University Hospital Hradec Kralove
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Patients with diagnosed communicating hydrocephalus
- mini-mental state examination test > 10 points
- Absence of any structural lesion on MRI or CT
- Accepted Informed consent
- Non-communicating hydrocephalus
- Structural lesion on MRI or CT (tumour, contusion, aneurysm)
- mini-mental state examination test < 10 points
- Life-expectancy shorter than 1 year
- Pre-existing other type of dementia (m. Alzheimer, vascular dementia)
- Surgery lasting more than 120 minutes
- Blood loss more than 500 ml
- Adverse events during general anesthesia: mean arterial pressure < 60 mm Hg more than 5 minutes, arrythmia with need for pharmacological treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of patient's state 3 month 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)
- Secondary Outcome Measures
Name Time Method Comparison in radiological findings 1 year Comparison of size of brain ventricles on brain CT examination at the end of follow-up between both groups
Comparison in number of valve setting 1 year Comparison in number of valve setting between both groups
Comparison of difference in valve settings 1 year Comparison of difference in valve settings - between pressure set in time of implantation and at the end of follow up
Trial Locations
- Locations (1)
University Hospital Hradec Kralove
🇨🇿Hradec Králové, Czech Republic
University Hospital Hradec Kralove🇨🇿Hradec Králové, Czech Republic