Development of a Patient-reported Outcome Measure for Chiari Malformation and Syringomyelia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

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

60 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborator