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

NCT ID: NCT05825521

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-14
• Study Completion Date: 2023-12-31

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.

Conditions

Hydrocephalus; Cerebral Ventricle; Cerebrospinal Fluid; White Matter Fiber

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MRI

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

MRI

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens

Salouël, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Olivier BALEDENT, MD

Role: CONTACT

olivier.baledent@chu-amiens.fr

33 3 22 08 95 20

Facility Contacts

Olivier Baledent, DR

Role: primary

baledent.olivier@chu-amiens.fr

(33)322089520

Other Identifiers

PI2021_843_0117

Identifier Type: -

Identifier Source: org_study_id