Guillain-Barré syndrome
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
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 gelijk n
Exclusion criteria
Exclusion criteria: No exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IGOS will result in a large combined clinical database and biobank of patients with GBS with all the variants and subtypes. Expertise Groups will use this data/biobank to determine the processes that determine and predicts disease progression and recovery in GBS. This information will be used to develop predictive models that can predict the clinical course in individual patients with GBS. These prognostic models can guide selective therapeutic trails in the future with specific subtypes of patients to personalize the treatment and improve the prognosis of GBS. The main outcome measures for the clinical course are the GBS disability score, MRC sum score, Overall Neuropathy Limitations Scale (ONLS), Rasch-built Overall Disability Scale(R-ODS), Fatigue Severity Scale(FSS) en EurQoL. For children (IGOS-kids) the following outcome measures will be: GBS disability score, MRC sum score, GBS-kids score, Peds-QL, Peds-QL MFS, ACTIVLIM, FSS and ONLS dependent of the age of the patient. (See supplement 19 of the protocol) IGOS will be divided in expertise groups that will focus on specific research areas, including: • Prognostic modelling : development of models to predict clinical course and outcome • Treatment interventions : defining treatment practice, effects and side-effects • Pharmacokinetics of IVIg : defining serum IgG levels after IVIg in relation to outcome • Electrophysiology : prognostic relevance of electrophysiological classification • Preceding events : defining type of infections/vaccinations related to GBS and outcome • Anti-neural antibodies : characterisation of serum antibodies related to GBS and outcome • CSF biomarkers : proteomic studies of CSF in relation to GBS and outcome • Genetic markers : genetic studies to define polymorphisms related to GBS and outcome • Paediatric GBS : characterisation of clinical course and outcome in children with GBS (IGOS-Kids) • Long-term outcome : residual disability and impact 2 and 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Besides the above clinical outcome measures IGOS will investigate several other GBS-related clinical effects, including autonomic dysfunction, and transition to chronic inflammatory demyelinating polyneuropathy. | — |
Countries
Netherlands
Outcome results
None listed