European Study of Prodromal iNPH

NCT05910944 · tracked via the Priya Life Science Italy tracker

Sponsor

Johan Virhammar

Phase

Observational

Started

2023-11-01

Last updated

2026-04-30

Condition(s) studied

Normal Pressure HydrocephalusHydrocephalus

Investigational drug(s) / intervention(s)

Shunt surgery

Shunt surgery: Shunt surgery according to each local centers routine

Study summary

To investigate if progression from prodromal into symptomatic NPH can be predicted from advanced neuroimaging, biomarkers in cerebrospinal fluid (CSF) and plasma and investigate the unknown mechanisms causing deterioration by investigating longitudinal changes in the above-mentioned variables. Three different cohorts with both asymptomatic and symptomatic patients as well as healthy controls will be investigated over time, both without intervention and before and after shunt surgery.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Accepted

Inclusion criteria - Group 1 - prodromal iNPH * Brain imaging with both: * Evans index \> 0.3 * Callosal angle ≤ 90 º or: * Disproportionately enlarged subarachnoid space hydrocephalus (DESH) - defined as: enlarged ventricles, dilated sylvian fissures and tight sulci at the high convexity. * Absence of symptoms or too mild symptoms to motivate shunt surgery according to local routine, and all of the following: * Normal gait pattern, or slight disturbance of the gait pattern that is not considered to be caused by a disease in the central nervous system (CNS). * Gait velocity (maximum gait speed), men ≥ 1.4 m/s; women ≥ 1.25 m/s. * Rombergs test with eyes open \> 60 seconds * Mini Mental State Examination (MMSE) ≥ 27 or Montreal Cognitive Assessment (MoCA) ≥ 23 * Informed consent Exclusion criteria - Group 1 - prodromal iNPH * Contraindication for MRI * Other serious disease with expected survival less than three years * Other type of hydrocephalus: * non-communicating hydrocephalus * secondary communicating hydrocephalus * suspected congenital hydrocephalus (severely enlarged ventricles, narrow sylvian fissures and normal non-compressed sulci at the high convexity or morphological findings consistent with PaVM18) * Anticoagulants in a dose that hinders lumbar puncture Inclusion criteria - Group 2 - healthy controls • Age \> 65 years Exclusion criteria - Group 2 - healthy controls: * Imaging findings meet inclusion criteria of Group 1 * Previously known relevant neurological disease * Pathological gait pattern with unknown reason. * MMSE \< 27 or MoCA \< 26. * Anticoagulants in a dose that hinders lumbar puncture Inclusion criteria Group 3 symptomatic iNPH * iNPH diagnosis according to international guidelines.19 * Age matched with the individual in Group 1 (+/- 3 years) Exclusion criteria Group 3 symptomatic iNPH * Previous stroke (clinical stroke, not only radiologically verified) * Other serious disease with expected survival less than three years

Primary outcome measure(s)

Frequency of patients with prodromal iNPH that requires shunt surgery within 6 years from inclusion. — From date of inclusion until decision of shunt surgery, assessed up to 72 months
Symptoms are assessed with the idiopathic Normal Pressure Hydrocephalus scale (iNPH-scale) with addition of the gait tests: 10 meter walking in maximum speed, timed up and go test (TUG) and 3 m walking backwards. Each center decides when symptoms have progressed enough to motivate shunt surgery according to local traditions and routine. Low values in time and steps of the gait tests indicate good performance and high values of the iNPH-scale (range: 0-100) indicates good performance.
Frequency of patients with prodromal iNPH that progress to symptomatic iNPH — From date of inclusion until 20 points reduction in total iNPH-scale score or 20% reduction in gait speed, assessed up to 72 months
Symptoms are assessed with the iNPH-scale with addition of the gait tests: 10 meter walking in maximum speed, timed up and go test (TUG) and 3 m walking backwards. A patient is considered symptomatic when total iNPH-scale is reduced by at least 20 points or the mean speed of the gait tests are reduced by 20%. Low values in time and steps of the gait tests indicate good performance and high values of the iNPH-scale (range: 0-100) indicates good performance.
Post operative improvement in iNPH-scale score in patients with mild, moderate and severe preoperative symptoms — Change from preoperative (last visit before surgery) iNPH scale at 3 months, 12 months, 36 months and 60 months follow-up.
Differences in short (3 and 12 months) and long-term outcome (36 and 60 months) measured as change between preoperative and postoperative iNPH-scale score will be compared between patients with mild, moderate and severe preoperative symptoms. High values of the iNPH-scale (range: 0-100) indicates good performance.

Trial sites (7)

Facility	City	Region	Status
Kuopio University Hospital	Kuopio	Finland	Not Yet Recruiting
Bellaria Hospital	Bologna	Italy	Recruiting
Sahlgrenska University Hospital	Gothenburg	Sweden	Not Yet Recruiting
Linköping University Hospital	Linköping	Sweden	Not Yet Recruiting
Karolinska University Hospital	Stockholm	Sweden	Not Yet Recruiting
Umeå University Hospital	Umeå	Sweden	Not Yet Recruiting
Uppsala University Hospital	Uppsala	Sweden	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05910944 on ClinicalTrials.gov ↗ ← All trials in Italy