NCT07720206

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
37mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

June 8, 2026

Last Update Submit

July 17, 2026

Conditions

Keywords

Chiari malformationspinal cordcentral canalMRsyringomyelia

Outcome Measures

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.

    At inclusion (D0)

Secondary Outcomes (5)

  • Protrusion of the cerebellar tonsils

    at inclusion (day 0)

  • Presence and dimensions of syringomyelia

    At inclusion (day 0)

  • Distance between the obex and the foramen magnum

    At inclusion (Day 0)

  • Diffusion MRI parameter (1)

    At inclusion (Day 0)

  • Diffusion MRI parameter (2)

    At inclusion (Day 0)

Study Arms (2)

Patients with Chiari malformation with associated syringomyelia

EXPERIMENTAL
Procedure: MRI

Patients with Chiari malformation without associated syringomyelia

EXPERIMENTAL
Procedure: MRI

Interventions

MRIPROCEDURE

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

Patients with Chiari malformation with associated syringomyeliaPatients with Chiari malformation without associated syringomyelia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bordeaux university hospital

Bordeaux, France

Location

MeSH Terms

Conditions

Arnold-Chiari MalformationSyringomyelia

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSpinal Cord DiseasesCentral Nervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: single-center, prospective, cross-sectional, descriptive study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

July 22, 2026

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

September 30, 2029

Last Updated

July 22, 2026

Record last verified: 2026-07

Locations