NL-OMON47523RecruitingNot Applicable
International GBS Outcome Study A prospective INC study on clinical and biological predictors of disease course en outcome in GBS - IGOS
Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites200 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 2 to 99 (—)
Inclusion Criteria
- •Criteria for inclusion of patients in the IGOS:
- •Fulfil the diagnostic criteria for GBS of the National Institute of
- •Neurological Disorders and Stroke (NINDS). In addition all patients with Miller
- •Fisher syndrome (MFS) and other variants of GBS, including overlap syndromes
- •can be included, for which additional diagnostic criteria will be provided.
- •Inclusion of all males and females of all ages, independent of disease
- •severity and treatment
- •Inclusion within two weeks of onset of weakness. In IGOS-Kids, children
- •should be included within four weeks of onset of weakness. In IGOS-Infections,
- •patients should be included within 8 weeks after onset of weakness.
- •Inclusion of patients transferred from another hospital if the stay in the
- •first hospital was less than one week. In IGOS-Infections patients can still be
- •included if the stay in another hospital was more than one week.
- •Opportunity to conduct a follow-up of at least one year. In IGOS-Infections
- •and IGOS-Zika opportunity to follow-up at least 6 months.
- •In IGOS-Infections: suspected antecedent infection related to GBS.
- •Informed consent of the patient or, in case of children, of the parents or
- •legal guardiansCriteria for inclusion of patients in the optional research
- •modules of the IGOS: Additional informed consent is required for each optional
- •research module:
- •(1) CSF biomarkers: additional volume obtained at diagnostic spinal tap
- •(2) Long-term outcome: additional clinical assessments at two and three years
Exclusion Criteria
- •No exclusion criteria
Investigators
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