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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hydrocephalus Normal Pressure Hydrocephalus Normal Pressure Hydrocephalus Patients

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Study group "Telemetrics"

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

lumbar puncture

Intervention Type DIAGNOSTIC_TEST

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.

External lumbar drainage

Intervention Type DIAGNOSTIC_TEST

External lumbar drainage placement for assessing responsivity of external derivation of cerebrospinal fluid. It is test of responsivity to ventriculo-peritoneal shunt placement

Ventriculo-peritoneal shunt placement

Intervention Type PROCEDURE

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.

Follow-up control #1

Intervention Type DIAGNOSTIC_TEST

Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 3 month after surgery. Brain CT control.

Follow-up control #2

Intervention Type DIAGNOSTIC_TEST

Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 6 month after surgery. Brain CT control.

Follow-up control #3

Intervention Type DIAGNOSTIC_TEST

Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 9 months after surgery. Brain CT control.

Follow-up control #4

Intervention Type DIAGNOSTIC_TEST

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.

Telemetric prechamber reading

Intervention Type DIAGNOSTIC_TEST

Non-invasive reading of telemetric prechamber made during each follow-up control.

Valve setting change

Intervention Type OTHER

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.

Study group "Normal"

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

lumbar puncture

Intervention Type DIAGNOSTIC_TEST

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.

External lumbar drainage

Intervention Type DIAGNOSTIC_TEST

External lumbar drainage placement for assessing responsivity of external derivation of cerebrospinal fluid. It is test of responsivity to ventriculo-peritoneal shunt placement

Ventriculo-peritoneal shunt placement

Intervention Type PROCEDURE

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.

Follow-up control #1

Intervention Type DIAGNOSTIC_TEST

Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 3 month after surgery. Brain CT control.

Follow-up control #2

Intervention Type DIAGNOSTIC_TEST

Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 6 month after surgery. Brain CT control.

Follow-up control #3

Intervention Type DIAGNOSTIC_TEST

Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 9 months after surgery. Brain CT control.

Follow-up control #4

Intervention Type DIAGNOSTIC_TEST

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.

Valve setting change

Intervention Type OTHER

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.

Interventions

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lumbar puncture

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.

Intervention Type DIAGNOSTIC_TEST

External lumbar drainage

External lumbar drainage placement for assessing responsivity of external derivation of cerebrospinal fluid. It is test of responsivity to ventriculo-peritoneal shunt placement

Intervention Type DIAGNOSTIC_TEST

Ventriculo-peritoneal shunt placement

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.

Intervention Type PROCEDURE

Follow-up control #1

Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 3 month after surgery. Brain CT control.

Intervention Type DIAGNOSTIC_TEST

Follow-up control #2

Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 6 month after surgery. Brain CT control.

Intervention Type DIAGNOSTIC_TEST

Follow-up control #3

Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 9 months after surgery. Brain CT control.

Intervention Type DIAGNOSTIC_TEST

Follow-up control #4

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.

Intervention Type DIAGNOSTIC_TEST

Telemetric prechamber reading

Non-invasive reading of telemetric prechamber made during each follow-up control.

Intervention Type DIAGNOSTIC_TEST

Valve setting change

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No