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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group "Telemetrics" | Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber implantad. |
| |
| Study group "Normal" | Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber not implantad. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of patient's state | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison in radiological findings | 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 | Comparison in number of valve setting between both groups |
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Inclusion Criteria:
Exclusion Criteria:
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Patients selected based on inclusion criterias, with communicating hydrocephalus
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| Name | Affiliation | Role |
|---|---|---|
| Miroslav Cihlo, M.D. | University Hospital Hradec Kralove | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hradec Kralove | Hradec Králové | 50005 | Czechia |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Telemetric prechamber reading | Diagnostic Test | Non-invasive reading of telemetric prechamber made during each follow-up control. |
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| 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. |
|
| 1 year |
| Comparison of difference in valve settings | Comparison of difference in valve settings - between pressure set in time of implantation and at the end of follow up | 1 year |
| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| D006850 | Hydrocephalus, Normal Pressure |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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