Analysis of Disturbances in Neurofluid Dynamics in Type I Chiari Malformations

NCT06502431 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-02

No results posted yet for this study

Summary

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.

Conditions

  • Type I Chiari Malformation
  • Cerebral Hemodynamic
  • Craniospinal Hydrodynamic
  • Phase Contrast MRI
  • Cerebrospinal Fluid

Interventions

OTHER

phase contrast sequences

patients will benefit from phase contrast sequences complementary to the morphological MRI performed as part of the patient management.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-24
Primary Completion
2025-04-01
Completion
2027-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06502431 on ClinicalTrials.gov