Status:
UNKNOWN
Adjustable Gravitational vs. Adjustable Differential Pressure Valves in iNPH
Lead Sponsor:
Military University Hospital, Prague
Conditions:
Normal Pressure Hydrocephalus
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief Summary
The goal of the study is to verify theoretical benefit of ventriculoperitoneal shunting with MIETHKE M.blue® valve in patients with iNPH. The study is designed to assess walking and balance, urinary f...
Detailed Description
Patients who will be referred to Military University Hospital Prague with suspicion of normal pressure hydrocephalus will be tested by conventional methods to consider implantation of a ventriculo-per...
Eligibility Criteria
Inclusion
- Age of patients (between 60 and 85 years old)
- Clinically suspected Normal Pressure Hydrocephalus (NPH) with at least gait and one other symptom from Hakim-Adams triad (incontinence or dementia)
- maximal initial pressure of 20 cmH2O during lumbar infusion test
- Rout during LIT \>9mmHg/ml\*min
- at least 15% improvement in Gait scale score after ELD
- Conclusion of neuropsychological examination suggestive of iNPH (based on MoCA, Test of phonemic and verbal fluency, RAVLT, ROCFT, TMT A and B, Subtest of WAIS III, GDS)
Exclusion
- Aetiology of hydrocephalus other than idiopathic normal pressure hydrocephalus (secondary normal pressure hydrocephalus - history of meningitis or subarachnoid haemorrhage, obstructive type of hydrocephalus - eg aqueductal stenosis, Blake's pouch cyst)
- Intracranial tumor
- Other neurodegenerative diseases may be present (AD, Parkinson's disease, Lewy body dementia, Progressive supranuclear palsy and cerebrovascular diseases), however have to be mild and evaluated in neurological, neuropsychological examinations and on MRI
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04434053
Start Date
January 1 2020
End Date
January 1 2023
Last Update
June 16 2020
Active Locations (1)
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1
Neurosurgical department of the Central Military Hospital, 1st Faculty of Medicine of Charles University
Prague, Czechia, 16902