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

NCT05825521 | Unknown

• 1 other identifier: PI2021_843_0117
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Hydrocephalus; cerebral ventricles; cerebrospinal fluid; white matter fibers; functional biomarkers

Outcome Measures

Primary Outcomes (2)

• Variation of MRI flow between both groups

  3 years

• Variation of MRI diffusion between both groups

  3 years

Study Arms (2)

Patients with hydrocephalus

EXPERIMENTAL

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

Controls

ACTIVE COMPARATOR

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

Interventions

MRI 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; Patients with hydrocephalus

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Salouël, 80480, France

RECRUITING

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Olivier BALEDENT, MD

CONTACT

33 3 22 08 95 20; olivier.baledent@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: December 14, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)