Status:
NOT_YET_RECRUITING
Development of a Patient-reported Outcome Measure for Chiari Malformation and Syringomyelia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Syringomyelia
Chiari Malformation
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06011226
Start Date
September 1 2023
End Date
December 1 2026
Last Update
September 21 2023
Active Locations (1)
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1
Hôpital Bicêtre - Service de Neurochirurgie - CRMR C-MAVEM
Le Kremlin-Bicêtre, France, 94270