- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07720206
Abnormality of the Central Canal of the Spinal Cord in Syringomyelia in a Patient With a Basal Skull Malformation (SYRCANAL)
The aim of this study is to analyze the association between a deformity of the cranial portion of the central spinal canal and syringomyelia in patients with a Chiari-type malformation of the craniocervical junction.
The investigators hypothesize that Chiari malformation, defined by the herniation of the cerebellar tonsils through the foramen magnum, may be responsible for a deformation of the cranial portion of the central spinal canal, and that this deformation is associated with the presence of syringomyelia in patients with this malformation.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Chiari Malformation Type I (CM-I) is a congenital anomaly characterized by downward displacement of the cerebellar tonsils through the foramen magnum, which may disrupt cerebrospinal fluid (CSF) circulation at the craniovertebral junction. The condition generally results from underdevelopment of the posterior cranial fossa, leading to insufficient space for the cerebellum. This anatomical abnormality can cause a wide range of heterogeneous symptoms, including occipital headaches triggered by coughing or exertion, neck pain, dizziness, balance disturbances, paresthesia, limb weakness, and swallowing difficulties.
One of the most concerning complications is syringomyelia/hydromyelia, which corresponds to the development of fluid-filled cavities within the spinal cord. These cavities may either be adjacent to the central canal (syringomyelia) or result from dilation of the central canal itself (hydromyelia). Associated spinal cord involvement may lead to specific neurological symptoms and is often a major indication for surgical treatment of Chiari malformation.
The decision to perform surgical decompression of the craniovertebral junction must balance the potential benefits against the associated risks. Furthermore, surgical outcomes remain variable and sometimes uncertain. Some symptoms may persist despite surgery, and syringomyelia regression is inconsistent. A better understanding of the pathophysiology of syringomyelia associated with Chiari malformation is therefore essential to improve patient selection and optimize surgical strategies.
Although the pathophysiology of syringomyelia in Chiari malformation has been investigated in several studies, it remains only partially understood. Recently, the position of the obex has been suggested to be associated with the presence of syringomyelia in patients with Chiari malformation. The obex is the neurological structure located at the cranial end of the central canal. Based on previous findings, investigators hypothesize that a low-lying obex may induce deformation of the central canal, creating a folding or kinking effect that could explain downstream canal dilation. Our primary hypothesis is therefore that the morphology of the central canal at the cervicomedullary junction (including angulation, folding, or compression) is a key factor influencing the presence or absence of associated hydromyelia/syringomyelia and, consequently, clinical severity.
Animal studies support a pathophysiological cascade involving initial mechanical deformation of the central canal followed by pericanal inflammation contributing to syringomyelia formation. According to this novel hypothesis, cerebellar tonsillar descent without associated central canal deformation would confer a lower risk of syringomyelia and unfavorable clinical progression than cases involving deformation of the cranial portion of the central canal.
In vivo visualization and morphological assessment of the cranial portion of the ependymal central canal using MRI therefore offer the potential to identify new risk markers for Chiari malformation that may ultimately assist surgical decision-making. However, when the canal is not dilated, visualization remains challenging, as does the identification of potential pericanal inflammation.
Several years ago, Tourdias et al. developed a specific MRI sequence known as White Matter-nulled (WMn) MPRAGE, which enhances contrast between structures of the central nervous system, including the thalamus, thereby improving the accuracy of thalamic assessment in pathological conditions. More recently, this group demonstrated that the WMn-MPRAGE sequence can be adapted for spinal cord imaging, maximizing the detection of spinal cord lesions. In collaboration with the Anatomy Laboratory of the University of Bordeaux, it was demonstrated that WMn-MPRAGE enables reliable visualization of the spinal cord central canal in healthy subjects when compared with previous anatomical specimen studies. Furthermore, recent advances in spinal cord diffusion MRI, particularly through artificial intelligence-based denoising methods, now enable detailed assessment of spinal cord microstructure and may allow quantification of biomarkers associated with pericanal inflammation.
Thus, the pathophysiology of Chiari Malformation Type I remains incompletely understood. Investigators hypothesize that analysis of the morphology of the cranial portion of the ependymal central canal using WMn-MPRAGE imaging, combined with assessment of the adjacent spinal cord microstructure, may provide novel biomarkers of associated syringomyelia risk and clinical severity.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Jean-Rodolphe VIGNES, Pr
- Telefonnummer: +33 05 57 95 54 43
- E-Mail: jean-rodolphe.vignes@chu-bordeaux.fr
Studieren Sie die Kontaktsicherung
- Name: Paul ROBLOT, Dr
- Telefonnummer: +33 05 56 79 55 43
- E-Mail: paul.roblot@chu-bordeaux.fr
Studienorte
-
-
-
Bordeaux, Frankreich
- Bordeaux University Hospital
-
Kontakt:
- Jean-Rodolphe VIGNES, PR
- Telefonnummer: +33 05 56 79 55 43
- E-Mail: jean-rodolphe.vignes@chu-bordeaux.fr
-
Hauptermittler:
- Jean-Rodolphe VIGNES, Pr
-
Unterermittler:
- Paul ROBLOT, Dr
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Adult patients being treated for Chiari malformation or syringomyelia at Bordeaux University Hospital
- Patients admitted for an initial surgical consultation regarding Chiari malformation with or without syringomyelia at Bordeaux University Hospital
- Individuals enrolled in or covered by a social security program.
- Free, informed, and express consent (confirmed in writing) (no later than the day of enrollment and prior to any examination required by the study).
Exclusion Criteria:
- Pregnant or breastfeeding patients
- Contraindications to MRI
- Individuals deprived of their liberty by judicial or administrative order,
- Adults subject to legal protective measures (guardianship, conservatorship, judicial protection).
- Patients who have previously undergone surgery for a Chiari malformation or a posterior fossa malformation
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Patients with Chiari malformation with associated syringomyelia
|
Magnetic Resonance Imaging (MRI) using T1, T2, White-Matter nulled (WMn), and diffusion sequences
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Experimental: Patients with Chiari malformation without associated syringomyelia
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Magnetic Resonance Imaging (MRI) using T1, T2, White-Matter nulled (WMn), and diffusion sequences
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Deformation of the central canal of the spinal cord
Zeitfenster: At inclusion (D0)
|
The central canal deformation index of the spinal cord, calculated based on the angle of the curves and the length of each segment between two curves.
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At inclusion (D0)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Protrusion of the cerebellar tonsils
Zeitfenster: at inclusion (day 0)
|
Protrusion of the cerebellar tonsils into the foramen magnum on T2-weighted MRI. Commonly accepted definition of Chiari malformation Type I: cerebellar tonsils extending more than 5 mm below the McRae line on MRI. The McRae line is defined as the anatomical line connecting the basion and the opisthion, corresponding to the anterior and posterior margins of the foramen magnum. |
at inclusion (day 0)
|
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Presence and dimensions of syringomyelia
Zeitfenster: At inclusion (day 0)
|
The presence and dimensions of syringomyelia on MRI using T2 and WMn-MPRAGE sequences
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At inclusion (day 0)
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Distance between the obex and the foramen magnum
Zeitfenster: At inclusion (Day 0)
|
Distance between the obex and the foramen magnum on T2-weighted and WMn-MPRAGE MRI sequences
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At inclusion (Day 0)
|
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Diffusion MRI parameter (1)
Zeitfenster: At inclusion (Day 0)
|
Diffusion MRI parameter (mean diffusivity) in the pericanalicular region
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At inclusion (Day 0)
|
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Diffusion MRI parameter (2)
Zeitfenster: At inclusion (Day 0)
|
Diffusion MRI (anisotropy fraction) in the pericanalicular region
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At inclusion (Day 0)
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CHUBX 2026/003
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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