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Abnormality of the Central Canal of the Spinal Cord in Syringomyelia in a Patient With a Basal Skull Malformation (SYRCANAL)

17 de julho de 2026 atualizado por: University Hospital, Bordeaux

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.

Visão geral do estudo

Status

Ainda não está recrutando

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

50

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

      • Bordeaux, França
        • Bordeaux University Hospital
        • Contato:
        • Investigador principal:
          • Jean-Rodolphe VIGNES, Pr
        • Subinvestigador:
          • Paul ROBLOT, Dr

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Patients with Chiari malformation with associated syringomyelia
Magnetic Resonance Imaging (MRI) using T1, T2, White-Matter nulled (WMn), and diffusion sequences
Experimental: Patients with Chiari malformation without associated syringomyelia
Magnetic Resonance Imaging (MRI) using T1, T2, White-Matter nulled (WMn), and diffusion sequences

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Deformation of the central canal of the spinal cord
Prazo: 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.
At inclusion (D0)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Protrusion of the cerebellar tonsils
Prazo: 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)
Presence and dimensions of syringomyelia
Prazo: At inclusion (day 0)
The presence and dimensions of syringomyelia on MRI using T2 and WMn-MPRAGE sequences
At inclusion (day 0)
Distance between the obex and the foramen magnum
Prazo: At inclusion (Day 0)
Distance between the obex and the foramen magnum on T2-weighted and WMn-MPRAGE MRI sequences
At inclusion (Day 0)
Diffusion MRI parameter (1)
Prazo: At inclusion (Day 0)
Diffusion MRI parameter (mean diffusivity) in the pericanalicular region
At inclusion (Day 0)
Diffusion MRI parameter (2)
Prazo: At inclusion (Day 0)
Diffusion MRI (anisotropy fraction) in the pericanalicular region
At inclusion (Day 0)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

30 de setembro de 2026

Conclusão Primária (Estimado)

30 de setembro de 2029

Conclusão do estudo (Estimado)

30 de setembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

8 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de julho de 2026

Primeira postagem (Real)

22 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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