CompletedNot Applicable

Combined Flow and Pressure Study of Craniospinal Dynamic

France75 participantsStarted 2022-01-04

Plain-language summary

Normal pressure hydrocephalus (NPH) can cause a type of dementia. However, this type of dementia is the only one that is reversible. To treat this dementia it is necessary to evacuate the accumulation of CSF from the brain to another body cavity using a device called a shunt. But the implantation of this shunt is only effective when the cause of the pathology is an alteration of the normal circulation of the CSF. To diagnose these patients, morphological MRI and lumbar puncture are standard approaches used but remain perfectible in diagnostic terms. The main objective is to build a new model of the interaction of intracranial pressures and fluids in order to obtain a new parameter allowing to obtain information on the cerebral biomechanics.

Who can participate

Age range

55 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.

Inclusion Criteria: * age \> 55 years * Patients with suspected active hydrocephalus (HA) known as "normal pressure": * Ventricular dilatation: Evans index \> 0.3 * Patients with cognitive impairment, and/or gait disorders and/or urinary incontinence or a combination of these three symptoms. * Absence of other neurological diseases that could cause ventriculomegaly. * Information and collection of the patient's non opposition Exclusion Criteria: * All patients with neurological disease other than active hydrocephalus will be excluded. * Individuals who cannot tolerate an MRI examination * All individuals with implants, pacemakers, prostheses and ferromagnetic objects * Patients under guardianship, curators or safeguard of justice

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

Variation of number of MRICP parameters according of CSF accumulation

Timeframe: up to 3 years

Trial details

NCT IDNCT05068128

SponsorCentre Hospitalier Universitaire, Amiens

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-24

View on ClinicalTrials.gov More Intracranial Pressure trials