Development of a Patient-reported Outcome Measure for Chiari Malformation and Syringomyelia

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Aug 21, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on creating a tool that helps doctors understand how Chiari malformation and syringomyelia affect patients' daily lives. Chiari malformation happens when part of the brain, called the cerebellar tonsils, pushes down into the spinal area, which can block the flow of a fluid called cerebrospinal fluid. This can lead to a condition known as syringomyelia, where a fluid-filled cavity forms in the spinal cord. The researchers want to develop a way for patients to report their symptoms, which will help doctors provide better treatment and follow-up care.

To participate in this trial, you must be at least 18 years old and able to understand French. You should also have a confirmed diagnosis of either Chiari malformation or syringomyelia based on an MRI scan. If you decide to join, you will be asked to share your experiences and symptoms related to these conditions. This research is important because it aims to improve how these conditions are evaluated and treated, ultimately leading to better patient care. Please note that the trial is not yet recruiting participants, so more information will be available when it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Criteria common to all subjects included in the study
• • Age \> 18 years
• • Subject understanding French Patients included in Phase I
• • Subject with signed informed consent Patients included in phase II
• • Patient not opposed to study participation
• Patients Chiari only group:
• • Isolated descent of cerebellar tonsils \> 5 mm below McRae's line (no associated syringomyelia)
• Patients syringomyelia only group:
• • Presence of an intramedullary fluid cavity secondary to circulatory disturbance of cerebrospinal fluid of non foraminal origin (no Chiari)
• Patients Chiari with Syringomyelia group:
• • Presence of Chiari malformation (tonsils \> 5 mm below McRae's line) AND foraminal syringomyelia.
• Exclusion Criteria:
• • Insufficient command of French
• • Minor or protected adult (guardianship, curatorship, safeguard of justice)
• • Diagnosis of Chiari and/or syringomyelia not proven by an MRI scan
• • Pregnant or breast-feeding