Development of a Patient-reported Outcome Measure for Chiari Malformation and Syringomyelia (NCT06011226) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Development of a Patient-reported Outcome Measure for Chiari Malformation and Syringomyelia
France60 participantsStarted 2023-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
development of metrologic and psychometric features of a patient-reported outcome measure (Bicêtre Chiari and Syringomyelia score - BCS score)
Timeframe: throughout the study (an average of 26 months)
2
validation of metrologic and psychometric features of a patient-reported outcome
Timeframe: throughout the study (an average of 26 months)