Clinical trial NCT06629168: The Usage of Telemetric Prechamber Sensor Reservoir in Management of Normal Pressure Hydrocephalus. Comparisson of Benefit for Patients with Implanted Telemetric Prechamber Sensor Reservoir.
Official title: Usage of Telemetric Prechamber Sensor Reservoir in Management of Hydrocephalus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus
Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus Patients
Keywords: Normal pressure hydrocephalus
VP drainage
telemetry
pressure monitoring
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients selected based on inclusion criterias, with communicating hydrocephalus

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.

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosed communicating hydrocephalus
* mini-mental state examination test \> 10 points
* Absence of any structural lesion on MRI or CT
* Accepted Informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Comparison of patient's state
timeFrame: 3 month
Secondary outcomes:
measure: Comparison in radiological findings
timeFrame: 1 year
measure: Comparison in number of valve setting
timeFrame: 1 year
measure: Comparison of difference in valve settings
timeFrame: 1 year
Other outcomes:
Locations:
city: Hradec Králové
country: Czech Republic
facility: University Hospital Hradec Kralove
Study officials:
affiliation: University Hospital Hradec Kralove
name: Miroslav Cihlo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: