CompletedNot Applicable

The Role of the Glymphatic System Avaluated Thourgh mr Imaging in the Diagnosis and Management of NPH

Italy29 participantsStarted 2021-06-15

Plain-language summary

The goal of this observational study is to evaluate the role of DTI-ALPS in the diagnostic and therapeutic management of NPH The main questions it aims to answer are: * Whether the glymphatic system (GS) is actually impaired in NPH * Whether DTI-ALPS index can predict the positive response to tap test (TT) and to ventriculo-peritoneal shunt (VPS) surgery. A healthy control group of patients (HC group) matched for age with the study group, will undergo MR with DTI-ALPS study

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Suspected NPH patients according to the following: Inclusion Criteria: * clinical and radiological diagnosis of probable NPH according to existing guidelines * age of over 50 years Exclusion Criteria: * inability to undergo MR * diagnosis of any other neurological pathology, particularly neurodegenerative or neuroinflammatory * previous neurosurgical interventions on the brain of any type. * inability to undergo general anaesthesia

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparison between study and control group

Timeframe: 4 years

Trial details

NCT IDNCT06857136

SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08-31

View on ClinicalTrials.gov More Hydrocephalus trials