Brain scans and spinal fluid may predict hydrocephalus progression
NCT ID NCT05910944
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 140 people with early signs of normal pressure hydrocephalus (NPH) to see if brain scans and fluid tests can predict who will get worse and need shunt surgery. Participants include those with mild symptoms, those with clear NPH, and healthy volunteers. The goal is to understand how the disease progresses and improve treatment timing.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2023
- Expected to finish
-
Dec 2035
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients in Group 1 can be included from patients referred to a tertiary hydrocephalus center after investigations/work-up have shown too mild symptoms to motivate shunt surgery. Healthy age-matched controls (Group 2) can be included by advertising and by asking relatives to patients in Group 1 and Group 3. For each included individual in Group 1 (prodromal iNPH), two patients are included in Group 3 (symptomatic iNPH). These patients are consecutively included at each center from routine patients that are planned for shunt surgery. They should be age matched with the individual in Group 1 (+/- 3 years).
- Ages
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hydrocephalus are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
7 sites in 3 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Bellaria Hospital
RECRUITINGBologna, Italy
-
Karolinska University Hospital
NOT_YET_RECRUITINGStockholm, Sweden
-
Kuopio University Hospital
NOT_YET_RECRUITINGKuopio, Finland
-
Linköping University Hospital
NOT_YET_RECRUITINGLinköping, Sweden
-
Sahlgrenska University Hospital
NOT_YET_RECRUITINGGothenburg, Sweden
-
Umeå University Hospital
NOT_YET_RECRUITINGUmeå, Sweden
-
Uppsala University Hospital
RECRUITINGUppsala, Sweden
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can MRI flow measurements improve normal pressure hydrocephalus diagnosis?
- Wireless skin sensor aims to detect silent shunt failures
- Radiation-Free brain imaging for kids? ultrasound may offer a safer path
- Can a Brain-Stiffness scan spot a treatable form of dementia?
- Wearable device could monitor brain shunt function from home
- Keyhole brain surgery could spare children from shunt complications