Programmable versus fixed anti-siphon devices for normal pressure hydrocephalus

Multicentre randomized trial evaluating the efficacy and safety of programmable compared with fixed anti-siphon devices for idiopathic normal pressure hydrocephalus (iNPH) in adults

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13838310

Enrollment

306

Registered

2016-11-10

Start date

2016-12-01

Completion date

Unknown

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic normal pressure hydrocephalus (iNPH) Nervous System Diseases Idiopathic normal pressure hydrocephalus (iNPH)

Interventions

Participants are randomised to one of two groups immediately before surgery using the web-based randomization and documentation platform (SecuTrialTM). A block randomization scheme with a block length

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Cumulative incidence of over- or underdrainage is measured through clinical observations 6 months post-surgery.	—

Secondary

Measure	Time frame
1. Individual rates of overdrainage measured by clinical evaluation at 3, 6 and 12 months 2. Individual rates of underdrainage measured by clinical evaluation at 3, 6 and 12 months 3. Slit ventricle syndrome as detected by CT imaging at 3, 6 and 12 months 4. Subdural effusions as detected by CT imaging at 3, 6 and 12 months 5. Infections measured by clinical evaluation at 3, 6 and 12 months 6. Neurofunctional outcomes measured by Kiefer Score, Black Grading Scale, 10 min walk test and 360° test at baseline, 3, 6 and 12 months 7. Health-related quality of life measured by SF-12 and EQ-5D at baseline, 3, 6 and 12 months	—

Measure

Time frame

1. Individual rates of overdrainage measured by clinical evaluation at 3, 6 and 12 months 2. Individual rates of underdrainage measured by clinical evaluation at 3, 6 and 12 months 3. Slit ventricle syndrome as detected by CT imaging at 3, 6 and 12 months 4. Subdural effusions as detected by CT imaging at 3, 6 and 12 months 5. Infections measured by clinical evaluation at 3, 6 and 12 months 6. Neurofunctional outcomes measured by Kiefer Score, Black Grading Scale, 10 min walk test and 360° test at baseline, 3, 6 and 12 months 7. Health-related quality of life measured by SF-12 and EQ-5D at baseline, 3, 6 and 12 months

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026