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

Primary Purpose

Hydrocephalus, Cerebral Ventricle, Cerebrospinal Fluid

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hydrocephalus focused on measuring Hydrocephalus, cerebral ventricles, cerebrospinal fluid, white matter fibers, functional biomarkers

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with hydrocephalus

Controls

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Variation of MRI flow between both groups
Variation of MRI diffusion between both groups

Secondary Outcome Measures

Full Information

First Posted
April 11, 2023
Last Updated
April 25, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT05825521
Brief Title
Impact of Cerebral Ventricular Dilatations and Cerebrospinal Fluid Pulsations on Periventricular White Matter in Hydrocephalic Patients
Acronym
HYDRODIFF
Official Title
Impact of Cerebral Ventricular Dilatations and Cerebrospinal Fluid Pulsations on Periventricular White Matter in Hydrocephalic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrocephalus, Cerebral Ventricle, Cerebrospinal Fluid, White Matter Fiber
Keywords
Hydrocephalus, cerebral ventricles, cerebrospinal fluid, white matter fibers, functional biomarkers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with hydrocephalus
Arm Type
Experimental
Arm Description
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.
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
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
Primary Outcome Measure Information:
Title
Variation of MRI flow between both groups
Time Frame
3 years
Title
Variation of MRI diffusion between both groups
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier BALEDENT, MD
Phone
33 3 22 08 95 20
Email
olivier.baledent@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Salouël
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Baledent, DR
Phone
(33)322089520
Email
baledent.olivier@chu-amiens.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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