Syringomyelia Clinical Trial
— BCS-scoreOfficial title:
Development of a Patient-reported Outcome Measure for Chiari Malformation and Syringomyelia
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Bicêtre - Service de Neurochirurgie - CRMR C-MAVEM | Le Kremlin-Bicêtre |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Institut National de la Santé Et de la Recherche Médicale, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | development of metrologic and psychometric features of a patient-reported outcome measure (Bicêtre Chiari and Syringomyelia score - BCS score) | Development of metrologic and psychometric features of a patient-reported outcome measure (BicĂȘtre Chiari and Syringomyelia score - BCS score) for evaluating functional severity of Chiari malformation and/or syringomyelia | throughout the study (an average of 26 months) | |
Primary | validation of metrologic and psychometric features of a patient-reported outcome | validation of metrologic and psychometric features of a patient-reported outcome measure (BicĂȘtre Chiari and Syringomyelia score - BCS score) for evaluating functional severity of Chiari malformation and/or syringomyelia | throughout the study (an average of 26 months) |
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