REVERT: Combined Flow and Pressure Study of Craniospinal Dynamic

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05068128

Collaborator

University Hospital, Caen (Other), University Hospital, Brest (Other)

Enrollment

Location

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Pressure Cerebral Blood Flows Infusion Test Phase Contrast MRI Hydrocephalus Dementia	Other: Flow MRI Other: PERFUSION TEST

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Outcome Measures

Primary Outcome Measures

Variation of number of MRICP parameters according of CSF accumulation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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