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Spinal fluid test may predict shunt success in hydrocephalus patients

NCT ID NCT05915000

Knowledge-focused Sponsor: University of Valencia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
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This status has not been confirmed recently, so it may be out of date.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 looks at whether certain proteins in spinal fluid can predict which adults with chronic hydrocephalus will improve after a shunt surgery. About 150 participants will have their fluid tested for amyloid and tau proteins, then tracked for changes in thinking, walking, and brain size after the procedure. The goal is to reduce the 20-25% of patients who currently get little to no benefit from the surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors identify which patients are most likely to improve after shunt surgery, avoiding unnecessary procedures for those who won't benefit.
What could go wrong
This is an observational study, not a treatment trial. It may not find clear protein markers, and results may not change current practice for years.

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 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2019

Expected to finish

Dec 2029

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

The study sample will be made up only of patients who meet the suspected diagnosis of adult chronic hydrocephalus, who are the ones who are going to have the valve implanted and followed up over time. In addition, the sample will be extracted with the biomarkers. The presence or absence of these biomarkers and their levels will be correlated with the clinical evolution of the patients so that these biomarkers could be used as prognostic indicators or to early identify those subjects in whom the cause of the symptoms was not really hydrocephalus but incipient dementia of another type (or other pathology).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Minimum age of 18 years, there is no maximum age, especially if it is understood that this pathology is more frequent as one advance in age, especially among males; pathology compatible with chronic adult hydrocephalus Exclusion Criteria: * All patients whose suspected diagnosis is not adult chronic hydrocephalus will be excluded, specifically those with cerebrovascular disease, dementia not due to adult chronic hydrocephalus, Alzheimer's disease, Parkinson's disease, and hereditary degenerative brain pathology. Huntington's chorea

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction hydrocephalus normal pressure hydrocephalus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Beta-amiloid and phospho-tau proteins in CSF Cognitive impairment and CSF shunt Motor impairment evolution after CSF shunt Ventricular size after CSF shunt

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • Hospital General Universitario de Valencia

    RECRUITING

    Valencia, Valencia, 46015, Spain

  • Vicente Vanaclocha

    RECRUITING

    Valencia, Valencia, 46015, Spain