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

January 22, 2025 updated by: Miroslav Cihlo, University Hospital Hradec Kralove

Usage of Telemetric Prechamber Sensor Reservoir in Management of Hydrocephalus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Králové, Czech Republic, 50005
        • University hospital Hradec Králové

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients selected based on inclusion criterias, with communicating hydrocephalus

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group "Telemetrics"
Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber implantad.
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
Diagnostic test: 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.
Procedure: 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.
Diagnostic test: 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.
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.
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.
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.
Diagnostic test: Telemetric prechamber reading
Non-invasive reading of telemetric prechamber made during each follow-up control.
Other: 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.
Study group "Normal"
Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber not implantad.
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
Diagnostic test: 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.
Procedure: 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.
Diagnostic test: 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.
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.
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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of patient's state
Time Frame: 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)
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison in radiological findings
Time Frame: 1 year
Comparison of size of brain ventricles on brain CT examination at the end of follow-up between both groups
1 year
Comparison in number of valve setting
Time Frame: 1 year
Comparison in number of valve setting between both groups
1 year
Comparison of difference in valve settings
Time Frame: 1 year
Comparison of difference in valve settings - between pressure set in time of implantation and at the end of follow up
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Hradec Kralove

Investigators

  • Principal Investigator: Miroslav Cihlo, M.D., University hospital Hradec Králové

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC00003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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