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Brain scans and spinal fluid may predict hydrocephalus progression

NCT ID NCT05910944

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.

  1. The places running it

    7 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Bologna, Italy

  • Karolinska University Hospital

    NOT_YET_RECRUITING

    Stockholm, Sweden

  • Kuopio University Hospital

    NOT_YET_RECRUITING

    Kuopio, Finland

  • Linköping University Hospital

    NOT_YET_RECRUITING

    Linköping, Sweden

  • Sahlgrenska University Hospital

    NOT_YET_RECRUITING

    Gothenburg, Sweden

  • Umeå University Hospital

    NOT_YET_RECRUITING

    Umeå, Sweden

  • Uppsala University Hospital

    RECRUITING

    Uppsala, Sweden

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