About this trial
Chiari malformation corresponds to the herniation of cerebellar tonsils into the foramen magnum resulting in obstruction of cerebrospinal fluid circulation, which may eventually lead to the formation of an intramedullary cavity called syringomyelia.
Chiari and syringomyelia can be responsible of variable symptoms, based on which neurosurgeons might propose surgical treatment. Yet, there is no properly developped and validated patient reported outcome measure (PROM) to assess the clinical severity of Chiari malformation and/or syringomyelia. The lack of such evaluation tool is a major issue to determine the optimal therapeutic strategy and to achieve a standardized and reproducible follow-up.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- focus groups
- questionnaire
Treatment groups
Sponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator