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

Hydrocephalus Clinical Trial

— HYDRODIFF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05825521
• Other study ID #: PI2021_843_0117
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2019
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Olivier BALEDENT, MD
• Phone: 33 3 22 08 95 20
• Email: olivier.baledent[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrospinal Fluid
• Hydrocephalus

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Salouël

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of MRI flow between both groups		3 years
Primary	Variation of MRI diffusion between both groups		3 years