Analysis of Disturbances in Neurofluid Dynamics in Type I Chiari Malformations (NEUROFLUX-C)

A global analysis of craniospinal hemodynamics and hydrodynamics is necessary to better understand the pathophysiology of Chiari malformations. This includes an analysis of intraventricular CSF flow, intracranial subarachnoid spaces, foramen magnum, cervical subarachnoid spaces and within the syringomyelia cavity when present. The investigators will also analyze the pulsatility of the cerebellar tonsils in the foramen magnum. Hemodynamic analysis will be performed at the high cervical level (internal carotid and vertebral arteries, jugular veins) and intracranially (carotid and basilar arteries, right sinus and superior longitudinal sinus). This analysis will be made possible by PCMRI acquisitions with slice planes allowing the analysis of the dynamics of the CSF (mesencephalic aqueduct, prepontic cisterns, foramen magnum, at the level of the C2C3 disc, syringomyelia if present), cerebellar tonsils (foramen magnum). The cross-sectional planes for hemodynamic analysis will be at the level of the C2C3 disc (cervical vascular analysis) and upstream of the polygon of Willis (intracranial vascular analysis).

The goal is to complement the clinical and morphological investigations with quantitative imaging of cerebrospinal fluid (CSF) and blood flow in the craniospinal system. These flows are potentially altered or causes of this Chiari anomaly.

The investigators propose a translational research project of clinical research allowing the analysis of a diagnostic technique by a diagnostic, monocentric, prospective study. After neurosurgical consultation, patients with Chiari malformation will be assigned to a symptomatic Chiari malformation or a non-symptomatic Chiari malformation group. They will be offered to participate in this study after information and informed consent. The allocation between the two groups will be made according to the symptomatic or non-symptomatic nature of the Chiari malformation. After inclusion, the patients will have a morphological MRI and a PCMRI according to the determined slice plans and allowing a global analysis of the craniospinal hemohydrodynamics. Craniospinal hemohydrodynamics in a control population will also be analyzed using the same methodology by PCMRI.

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebrospinal Fluid; Phase Contrast MRI; Type I Chiari Malformation; Cerebral Hemodynamic; Craniospinal Hydrodynamic
• Intervention / Treatment: Other: phase contrast sequences

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • CHU Amiens Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patients with major symptomatic or nonsymptomatic CMI
• aged 18 to 50 years
• no previous neurosurgical, neurological, or cardiological history.
• Controls should be age-matched to symptomatic CMI group. They should not have a history of neurosurgery, neurology, or cardiology.

Exclusion Criteria:

• Patients who are minors or over 50 years of age
• CMI invalidated by our radiological review
• Neurosurgical, neurological or cardiological history
• MRI contraindication
• pregnant, breast-feeding and parturient women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: phase contrast sequences; patients will benefit from phase contrast sequences complementary to the morphological MRI performed as part of the patient management.
Experimental: Symptomatic CMI group	Other: phase contrast sequences; patients will benefit from phase contrast sequences complementary to the morphological MRI performed as part of the patient management.
Experimental: Non-Symptomatic CMI group	Other: phase contrast sequences; patients will benefit from phase contrast sequences complementary to the morphological MRI performed as part of the patient management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CSF Flow	Flow will be measured by the oscillatory volume expressed in mL/cardiac cycle.	day 1
Blood Flow	Flow will be measured by the oscillatory volume expressed in mL/cardiac cycle.	day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Cerebrospinal fluid; Cerebral hemodynamic; Phase contrast MRI; Type I Chiari Malformation; Craniospinal hydrodynamic
• Additional Relevant MeSH Terms: Nervous System Diseases; Nervous System Malformations; Neural Tube Defects; Congenital Abnormalities; Arnold-Chiari Malformation
• Other Study ID Numbers: PI2023_843_0033

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
• product manufactured in and exported from the U.S.: No