The Usage of Telemetric Prechamber Sensor Reservoir in Management of Normal Pressure Hydrocephalus. Comparisson of Benefit for Patients with Implanted Telemetric Prechamber Sensor Reservoir.

University Hospital Hradec Kralove

Status: Completed

Conditions: Normal Pressure Hydrocephalus Patients; Hydrocephalus; Normal Pressure Hydrocephalus

Treatments: Diagnostic Test: Follow-up control #4; Diagnostic Test: External lumbar drainage; Diagnostic Test: Follow-up control #2; Diagnostic Test: lumbar puncture; Diagnostic Test: Follow-up control #1; Diagnostic Test: Telemetric prechamber reading; Diagnostic Test: Follow-up control #3; Other: Valve setting change; Procedure: Ventriculo-peritoneal shunt placement

Study type: Observational

Funder types: Other

Identifiers

NCT06629168

MC00003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

33 participants in 2 patient groups

Study group "Telemetrics"

Description:

Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber implantad.

Treatment:

Procedure: Ventriculo-peritoneal shunt placement

Other: Valve setting change

Diagnostic Test: Follow-up control #3

Diagnostic Test: Telemetric prechamber reading

Diagnostic Test: Follow-up control #1

Diagnostic Test: lumbar puncture

Diagnostic Test: Follow-up control #4

Diagnostic Test: Follow-up control #2

Diagnostic Test: External lumbar drainage

Study group "Normal"

Description:

Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber not implantad.

Treatment:

Procedure: Ventriculo-peritoneal shunt placement

Other: Valve setting change

Diagnostic Test: Follow-up control #3

Diagnostic Test: Follow-up control #1

Diagnostic Test: lumbar puncture

Diagnostic Test: Follow-up control #4

Diagnostic Test: Follow-up control #2

Diagnostic Test: External lumbar drainage