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Completed

NCT Number: 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.

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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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar puncture

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

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

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

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

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

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

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

Diagnostic Test

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

Valve setting change

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. Comparison in number of valve setting

    Time frame: 1 year

    Comparison in number of valve setting between both groups

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study title

Usage of Telemetric Prechamber Sensor Reservoir in Management of Hydrocephalus

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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