An interventional study of phase contrast sequences in Type I Chiari Malformation, Cerebral Hemodynamic and Craniospinal Hydrodynamic, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other
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.
34 studies on the registry are indexed under Arnold-Chiari Malformation; 10 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 18 interventional studies indexed under Arnold-Chiari Malformation.
Browse Arnold-Chiari Malformation studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: phase contrast sequences
Other: phase contrast sequences
Other: phase contrast sequences
patients will benefit from phase contrast sequences complementary to the morphological MRI performed as part of the patient management.
CSF Flow
Flow will be measured by the oscillatory volume expressed in mL/cardiac cycle.
Time frame: day 1
Blood Flow
Flow will be measured by the oscillatory volume expressed in mL/cardiac cycle.
Time frame: day 1
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2024 to primary completion in Apr 2025, 9 months.
Of 16 interventional studies with no phase under Arnold-Chiari Malformation, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 59. This study's 9 months is below that.
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Centre Hospitalier Universitaire, Amiens →