HYDRODIFF: Impact of Cerebral Ventricular Dilatations and Cerebrospinal Fluid Pulsations on Periventricular White Matter in Hydrocephalic Patients

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05825521

Collaborator

(none)

Enrollment

Location

Arms

47.6

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hydrocephalus is characterized by excessive accumulation of cerebrospinal fluid (CSF) in the ventricles of the brain. One of the forms of hydrocephalus is called "normal pressure", although one of the main signs is precisely an alteration of the intracranial pressure (ICP), it is here called active hydrocephalus (HA). Although MRI is the reference radiological modality for the characterization of HA. The Evan's and DESH index are radiological diagnostic criteria based on the dilation and morphology of the CSF compartments. These morphological indices remain insensitive and specific. In recent years, advances in Phase Contrast (MRI-PC) and Diffusion (MRI-DTI) MRI have generated new biomarkers of brain viability. The aim of this study is to characterize by MRI the impact of hydrocephalus on brain fluids and tissues.

Condition or Disease	Intervention/Treatment	Phase
Hydrocephalus Cerebral Ventricle Cerebrospinal Fluid White Matter Fiber	Other: MRI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Impact of Cerebral Ventricular Dilatations and Cerebrospinal Fluid Pulsations on Periventricular White Matter in Hydrocephalic Patients

Actual Study Start Date :

Dec 14, 2019

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with hydrocephalus Age > 55, Ventricular dilation: Evans Index > 0.3; Patients with cognitive impairment, and gait disturbances and/or urinary incontinence or a combination of these three symptoms; Absence of other neurological diseases that could cause ventriculomegaly, information and non-opposition.	Other: MRI During management, patients with hydrocephalus will be subjected to flow MRI and diffusion MRI. Flow parameters and diffusion parameters will be measured and compared to those found in control subjects receiving the same type of imaging
Active Comparator: Controls Age ≥ 55; No ventricular dilation: Evans Index < 0.3; Individuals who have no neurological or psychiatric disease; No neurological deficit. No history of neurosurgery or head trauma; signed informed consent; affiliation to a social security scheme.	Other: MRI During management, patients with hydrocephalus will be subjected to flow MRI and diffusion MRI. Flow parameters and diffusion parameters will be measured and compared to those found in control subjects receiving the same type of imaging

Arm

Intervention/Treatment

Experimental: Patients with hydrocephalus

Age > 55, Ventricular dilation: Evans Index > 0.3; Patients with cognitive impairment, and gait disturbances and/or urinary incontinence or a combination of these three symptoms; Absence of other neurological diseases that could cause ventriculomegaly, information and non-opposition.

Other: MRI

During management, patients with hydrocephalus will be subjected to flow MRI and diffusion MRI. Flow parameters and diffusion parameters will be measured and compared to those found in control subjects receiving the same type of imaging

Active Comparator: Controls

Age ≥ 55; No ventricular dilation: Evans Index < 0.3; Individuals who have no neurological or psychiatric disease; No neurological deficit. No history of neurosurgery or head trauma; signed informed consent; affiliation to a social security scheme.

Other: MRI

Outcome Measures

Primary Outcome Measures

Variation of MRI flow between both groups [3 years]
Variation of MRI diffusion between both groups [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

For Patients with hydrocephalus:
Age > 55,
Ventricular dilation: Evans Index > 0.3;
Patients with cognitive impairment, and gait disturbances and/or urinary incontinence or a combination of these three symptoms;
Absence of other neurological diseases that could cause ventriculomegaly, information and non-opposition.
For Controls:
Age ≥ 55;
No ventricular dilation: Evans Index < 0.3;
Individuals who have no neurological or psychiatric disease;
No neurological deficit.
No history of neurosurgery or head trauma;
signed informed consent;
affiliation to a social security scheme.

Exclusion Criteria:

All patients who have a neurological disease other than active hydrocephalus will be excluded;
Individuals unable to sign or understand consent;
Individuals with psychiatric, neurological or medical development;
Individuals under treatment with psychoactive drugs;
Individuals who cannot tolerate an MRI examination;
Any individual with implant, pacemaker, prosthesis and ferromagnetic object