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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • MRI

    Procedure/Surgery

    Magnetic Resonance Imaging (MRI) using T1, T2, White-Matter nulled (WMn), and diffusion sequences

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Patients with Chiari malformation with associated syringomyeliaExperimental treatment 1 intervention
Group B: Patients with Chiari malformation without associated syringomyeliaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Deformation of the central canal of the spinal cord

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.

Time frame
At inclusion (D0)

Secondary outcomes

1

Protrusion of the cerebellar tonsils

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.

Time frame
at inclusion (day 0)
2

Presence and dimensions of syringomyelia

The presence and dimensions of syringomyelia on MRI using T2 and WMn-MPRAGE sequences

Time frame
At inclusion (day 0)
3

Distance between the obex and the foramen magnum

Distance between the obex and the foramen magnum on T2-weighted and WMn-MPRAGE MRI sequences

Time frame
At inclusion (Day 0)
4

Diffusion MRI parameter (1)

Diffusion MRI parameter (mean diffusivity) in the pericanalicular region

Time frame
At inclusion (Day 0)

Other outcomes

Sponsors and contacts

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University Hospital, Bordeaux

Lead sponsor

University of Bordeaux

Collaborator

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