Combined Flow and Pressure Study of Craniospinal Dynamic

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.

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Key information

Conditions

Intracranial Pressure Brain Diseases Central Nervous System Diseases Cerebral Blood Flows Dementia Hydrocephalus Infusion Test Mental Disorders Nervous System Diseases Neurocognitive Disorders Phase Contrast MRI

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Salouël, 80480, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flow MRI

Other

4 flow acquisitions based on the 2D cine phase contrast sequence (present on all MRI systems) will be performed.

This sequence requires a cardiac synchronization by a plethysmograph put on the patient's finger.

32 cardiac phases are reconstructed per acquisition. The processing of the flow MRIs and the analysis of the flow curves of the LCS and blood during the cardiac cycle will be performed using the Amiens software.

Parameters measured via flow MRI are:

Cerebral vascular flow, intracranial LCS dynamic volume, extracranial LCS dynamic volume

PERFUSION TEST

Other

The test will be performed will include:

Inserting a needle into the lumbar space, Ommaya reservoir or valve pre-chamber, as appropriate
Connect the needle to the pressure transducer via saline filled manometer lines connected via a 3-way valve. The other end of the 3-way connection will be connected to a saline
Recording of the opening pressure for 10 minutes
The infusion test is terminated either when the pressure stabilizes again on a new plateau, or when the average pressure exceeds 40 mmHg, or in case of adverse effects or symptoms such as headache, nausea/vomiting or visual disturbances.
At the end of the test, a depletion of 30 to 50 mL of CSF will be performed.
The pressure recording during the test is then used to calculate the parameters of the mechanical properties of the CSF circulation and reported to the neurosurgeon ordering the test.

Primary outcomes

Variation of number of MRICP parameters according of CSF accumulation

Time frame: up to 3 years

The MRICP parameter will combine the CSF pressure and CSF flows. MRICP parameter results of the interaction of intracranial pressures and fluids in order allowing to obtain information on the cerebral biomechanics.

Accumulation of CSF from the brain to another body cavity is neccessary to be determined.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

University Hospital, Brest
University Hospital, Caen

Registry information

Official study title

Combined Flow-pressure Study of Cerebrospinal Circulation Using CSF Perfusion Tests and Phase-contrast MRI - Reversible Dementia Substudy

Acronym: REVERT

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Oct 5, 2021
Registry last updated: Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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