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

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.

Study Overview

• Status: Recruiting
• Conditions: Hydrocephalus; Cerebrospinal Fluid; Cerebral Ventricle; White Matter Fiber
• Intervention / Treatment: Other: MRI

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier BALEDENT, MD; Phone Number: 33 3 22 08 95 20; Email: olivier.baledent@chu-amiens.fr

Study Locations

• France
  • Salouël, France, 80480
    • Recruiting
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Variation of MRI flow between both groups	3 years
Variation of MRI diffusion between both groups	3 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: cerebrospinal fluid; Hydrocephalus; cerebral ventricles; white matter fibers; functional biomarkers
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus
• Other Study ID Numbers: PI2021_843_0117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No