Hydrocephalus, Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus Patients
Conditions
Keywords
Normal pressure hydrocephalus, VP drainage, telemetry, pressure monitoring
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.
Interventions
DIAGNOSTIC_TESTlumbar 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.
DIAGNOSTIC_TESTExternal 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
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_TESTFollow-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_TESTFollow-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_TESTFollow-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_TESTFollow-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_TESTTelemetric prechamber reading
Non-invasive reading of telemetric prechamber made during each follow-up control.
OTHERValve 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.
Sponsors
University Hospital Hradec Kralove
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of patient's state | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparison in radiological findings | 1 year | Comparison of size of brain ventricles on brain CT examination at the end of follow-up between both groups |
| Comparison in number of valve setting | 1 year | Comparison in number of valve setting between both groups |
| Comparison of difference in valve settings | 1 year | Comparison of difference in valve settings - between pressure set in time of implantation and at the end of follow up |
Countries
Czechia
Outcome results
None listed