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Development of a Patient-reported Outcome Measure for Chiari Malformation and Syringomyelia
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2023-09
Completion Date
2026-12
Last Updated
2023-09-21
Healthy Volunteers
No
Conditions
Interventions
focus groups
A dozen patients with Chiari malformation and syringomyelia (n = 4) or isolated Chiari malformation (n = 4) or isolated syringomyelia (n = 4) will be brought together in at least two focus groups. Each focus group will include 5 to 8 patients and will last approximately 1 to 2 hours. The focus groups will be recorded (audio only, no personal data will be collected during these sessions) and will be conducted in the presence of a neurosurgeon and a psychologist, who will moderate the session.
questionnaire
developed questionnaire will be proposed to the patients in phase 2 and 3
Locations (1)
Hôpital Bicêtre - Service de Neurochirurgie - CRMR C-MAVEM
Le Kremlin-Bicêtre, France