Programmable versus fixed anti-siphon devices for normal pressure hydrocephalus
Not Applicable
Completed
- Conditions
- Idiopathic normal pressure hydrocephalus (iNPH)Nervous System Diseases
- Registration Number
- ISRCTN13838310
- Lead Sponsor
- nfallkrankenhaus Berlin
- Brief Summary
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30333067 protocol
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 306
Inclusion Criteria
1. Aged 18 years and over
2. Meet clinical, physiological, functional and radiological diagnostic criteria of iNPH
2. Scheduled for VP shunting
4. Capable to understand the trial concept and its implications, and to provide written (or witnessed verbal) informed consent
Exclusion Criteria
1. Secondary NPH after infection, trauma, tumours, etc.
2. Contraindication for shunt surgery (e.g., malignant disease with reduced life expectancy, florid infections etc.)
3. Advanced dementia
4. Guardianship
5. Any impediment prohibiting informed consent
6. Patients with previous shunt implantation
7. Patients with previous ventriculostomy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative incidence of over- or underdrainage is measured through clinical observations 6 months post-surgery.
- Secondary Outcome Measures
Name Time Method 1. Individual rates of overdrainage measured by clinical evaluation at 3, 6 and 12 months <br>2. Individual rates of underdrainage measured by clinical evaluation at 3, 6 and 12 months <br>3. Slit ventricle syndrome as detected by CT imaging at 3, 6 and 12 months <br>4. Subdural effusions as detected by CT imaging at 3, 6 and 12 months <br>5. Infections measured by clinical evaluation at 3, 6 and 12 months <br>6. Neurofunctional outcomes measured by Kiefer Score, Black Grading Scale, 10 min walk test and 360° test at baseline, 3, 6 and 12 months <br>7. Health-related quality of life measured by SF-12 and EQ-5D at baseline, 3, 6 and 12 months