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International Guillain-Barré Syndrome Outcome Study (IGOS)

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Dr. B.C. Jacobs, Erasmus Medical Center
Information provided by (Responsible Party):
Dr. B.C. Jacobs, Erasmus Medical Center Identifier:
First received: April 20, 2012
Last updated: January 4, 2017
Last verified: January 2017

International GBS Outcome Study (IGOS) is a study conducted by the members of the Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease course and outcome in Guillain-Barré syndrome (GBS).

The IGOS aims to identify clinical and biological determinants and predictors of disease course and outcome in individual patients with Guillain-Barré syndrome, as early as possible after onset of disease.

Guillain-Barré Syndrome Miller Fisher Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International GBS Outcome Study (IGOS): A Prospective INC Study on Clinical and Biological Predictors of Disease Course and Outcome in Guillain-Barré Syndrome (GBS).

Resource links provided by NLM:

Further study details as provided by Dr. B.C. Jacobs, Erasmus Medical Center:

Primary Outcome Measures:
  • Guillain-Barre Syndrome(GBS) disability score and Medical Research Council(MRC) sumscore [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Overall Neuropathy Limitations Scale (ONLS) [ Time Frame: 1 year ]
  • Fatigue Severity Scale (FSS) [ Time Frame: 1 year ]
  • EurQol EQ-5D Health Questionnaire [ Time Frame: 1 year ]
  • Rasch-built Overall Disability Scale (R-ODS) [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
serum, cerebrospinal fluid, samples with DNA

Estimated Enrollment: 4000
Study Start Date: May 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Guillain-Barré syndrome >1000, follow-up 1-3 years
Normal controls (NC)
Infectious controls (IC)
Other neurological diseases (OND)

Detailed Description:

GBS is a post-infectious immune-mediated polyradiculoneuropathy with a highly diverse clinical course and outcome despite partially effective forms of treatment(immunoglobulins and plasma exchange). Outcome in patients with GBS has not improved in the last two decades. At present about 10 to 20% of patients remain severely disabled and about 5% die. One explanation for this stagnation is the highly variable clinical course of GBS and the lack of knowledge about the factors that determine the clinical course in individual patients with GBS. GBS may consist of distinct pathogenic subgroups, in which disease onset and progression is influenced by different types of preceding infections, anti-neural antibodies and genetic polymorphisms. Optimal treatment of individual patients may depend on the pathogenesis and clinical severity. Patients with severe forms of GBS may possibly need more intensive treatment to recover. Patients with a milder course that fully recover after standard therapy could suffer from possibly more side effects of more aggressive forms of treatment. This could only be possible if there are prognostic models that accurately predict the clinical course in individual patients. Ideally such models should be based on clinical and biological predictors that are strongly associated with disease course and known as early as possible in the acute phase of illness, when treatment with immunomodulatory therapy is most effective. Prognostic models could help to guide selective trials in specific GBS subtypes. Because of this it will be possible to treat GBS with more effective and more individual therapy.

This study aims to identify clinical and biological determinants and predictors of disease course and outcome in individual patients with Guillain-Barré syndrome, as early as possible after onset of disease. This information will be used to understand the diversity in clinical presentation and response to treatment of GBS. This information will also be used to develop new prognostic models to predict the clinical course and outcome accurately in individual patients with GBS.

To address these research questions it is required to conduct a prospective study with standardized collection of clinical data and biomaterials from a large group of well-defined GBS patients during a long follow-up period. Such an extensive study in a relatively rare disease as GBS can be addressed only by intensive international collaboration.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with Guillain-Barré syndrome (GBS) or variants of GBS, including the Miller Fisher syndrome (MFS) and overlap syndromes.

Inclusion Criteria:

  • Fulfil diagnostic criteria for GBS of National Institute of Neurological Disorders and Stroke (NINDS). Patients with Miller Fisher syndrome and all other variants of GBS, including overlap syndromes, can be included.
  • Inclusion of all males and females of all ages, independent of disease severity and treatment
  • Inclusion within two weeks of onset of weakness
  • Inclusion of patients transferred from another hospital if the stay in the first hospital was less than one week
  • Opportunity to conduct a follow-up of at least one year
  • Informed consent of patient or, in case of children, of parents or legal guardians

Exclusion Criteria:

  • There are no exclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01582763

Contact: Bianca van den Berg, Drs, MD 0031107042209
Contact: Bart C Jacobs, MD, DR, PHD 0031107043999

  Show 128 Study Locations
Sponsors and Collaborators
Erasmus Medical Center
Principal Investigator: Bart Jacobs, Dr. Erasmus Medical Center
  More Information

Additional Information:
Responsible Party: Dr. B.C. Jacobs, Principal Investigator, Erasmus Medical Center Identifier: NCT01582763     History of Changes
Other Study ID Numbers: MEC-2011-477
3290 ( Other Identifier: Dutch Trial Registration )
Study First Received: April 20, 2012
Last Updated: January 4, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. B.C. Jacobs, Erasmus Medical Center:
Guillain-Barré syndrome
Autoimmune Diseases
Immune System Diseases
Neuromuscular Diseases
Quality of life
Prognostic Determinants
Anti-ganglioside antibodies
Genetic polymorphisms
Cerebrospinal Fluid

Additional relevant MeSH terms:
Guillain-Barre Syndrome
Miller Fisher Syndrome
Pathologic Processes
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases processed this record on September 20, 2017