Idiopathic Normal-Pressure Hydrocephalus (INPH) in adults Nervous System Diseases Hydrocephalus
Conditions
Interventions
Experimental arm: ProGAV P3 (PGV, Miethke, Germany) Adjustable/Gravitational Valve
Control arm: Medos-Codman Programmable Valve System (CHPV, Codman Johnson & Johnson, Germany)
Sponsors
B. Braun Melsungen AG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects more than 18 years 2. High probability of Idiopathic Normal-Pressure Hydrocephalus (INPH), according to published guidelines and locally established protocols 3. The diagnosis will include clinical signs and symptoms (Hakim's triad), the findings from lumbal infusion and tap tests, intermittent drainage, and Computed Tomography (CT) results
Exclusion criteria
Exclusion criteria: 1. Secondary Normal-Pressure Hydrocephalus (NPH) to inflammation 2. Tumour 3. Post-traumatic states 4. Contraindications for surgery (e.g., severe underlying diseases, florid infections) 5. Severe dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite measure of: 1. Clinical signs and symptoms suggestive of overdrainage (e.g., headache, vomiting, dizziness) 2. Imaging results (e.g., subdural haematoma, slit-ventricle syndrome) 3. Therapeutic interventions to resolve overdrainage | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. INPH outcome scales and Recovery Rate 2. 12-item Short-Form health survey (SF-12) 3. Evans-Index 4. Complication rates 5. Adverse Events (AE) 6. Serious Adverse Events (SAE) | — |
Countries
Germany
Outcome results
None listed