International Guillain-Barré Syndrome Outcome Study (IGOS)

February 21, 2023 updated by: Dr. B.C. Jacobs, Erasmus Medical Center

International GBS Outcome Study (IGOS): A Prospective INC Study on Clinical and Biological Predictors of Disease Course and Outcome in Guillain-Barré Syndrome (GBS).

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Británico
      • Buenos Aires, Argentina
        • Hospital Garrahan
      • Buenos Aires, Argentina
        • Hospital Austral
      • Buenos Aires, Argentina
        • Hospital César Milstein
      • Buenos Aires, Argentina
        • Hospital de Clínicas
      • Buenos Aires, Argentina
        • Hospital Fleni
      • Buenos Aires, Argentina
        • Hospital Militar
  • Australia
      • Sydney, Australia
        • Concord Repatriation General Hospital Sydney
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Bangladesh
      • Dhaka, Bangladesh
        • Icddr,b
      • Dhaka, Bangladesh
        • Dhaka Medical College & Hospital
  • Belgium
      • Brussels, Belgium
        • Clinique Universitaire St. Luc
      • Leuven, Belgium
        • University Hospital Leuven
  • Canada
      • Calgary, Canada
        • University of Calgary
      • Kingston, Canada
        • Queens University
      • London, Canada
        • University hospital LHSC
      • Toronto, Canada
        • University Health Network
  • China
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
    • Hunan
      • Changsha, Hunan, China, 410000
        • Xiang Hospital Central South University
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • The Affiliated Hospital of Xuzhou Medical University
    • Shandong
      • Jining, Shandong, China, 272001
        • Affiliated hospital of Jining Medical University
  • Denmark
      • Aalborg, Denmark
        • Aalborg Hospital
      • Aarhus, Denmark
        • Aarhus University Hospital
      • Copenhagen, Denmark
        • National Hospital Copenhagen
      • Glostrup, Denmark
        • Glostrup Hospital Copenhagen
      • Odense, Denmark
        • Odense University Hospital
  • France
      • Marseille, France
        • Hospital De La Timone
      • Nantes, France
        • Nantes university hospital
      • Paris, France, 75016
        • Hôpital St. Louis de Paris
      • Strasbourg, France
        • University Strassbourg
  • Germany
      • Aachen, Germany
        • Universitätsklinikum der RWTH
      • Cologne, Germany
        • University of Cologne
      • Dresden, Germany
        • Universitätsklinikum Dresden
      • Duesseldorf, Germany
        • Heinrich Heine University
      • Homburg, Germany
        • University Hospital of Saarland
      • Würzburg, Germany
        • Universitätsklinikum Würzburg
  • Greece
    • Thessaly
      • Larissa, Thessaly, Greece
        • University of Thessaly
  • Italy
      • Genova, Italy
        • University of Genova
      • Milan, Italy
        • Ospedale San Raffaele
      • Milan, Italy
        • University of Milan
      • Milan, Italy
        • Ospedale Luigi Sacco
      • Modena, Italy
        • University of Modena
      • Monza, Italy
        • University of Milano-Bicocca
      • Napoli, Italy
        • Universita FedericoII di Napoli
      • Padova, Italy
        • University of Padova
      • Roma, Italy
        • Policlinico Tor Vergata
      • Rome, Italy
        • Sant' Andrea Hospital
      • la Spezia, Italy
        • Ospedale Sant'Andrea La Spezia
  • Japan
      • Chiba, Japan
        • Chiba University School of Medicine
      • Osaka, Japan
        • Kinki University School of Medicine
      • Sapporo, Japan
        • Hokkaido Medical Center
      • Tochigi, Japan
        • Dokkyo Medical Univeristy
      • Tokorozawa, Japan
        • National Defense Medical College
      • Tokyo, Japan
        • Toho University Medical Center
  • Malaysia
      • Kuala Lumpur, Malaysia
        • University of Malaya
  • Netherlands
      • Amsterdam, Netherlands
        • AMC Amsterdam
      • Apeldoorn, Netherlands
        • Gelre Ziekenhuis
      • Beverwijk, Netherlands
        • Rode Kruis Ziekenhuis
      • Delft, Netherlands
        • Reinier de Graaf Groep
      • Den Bosch, Netherlands
        • Jeroen Bosch Ziekenhuis
      • Den Haag, Netherlands
        • Haga ziekenhuis
      • Den Haag, Netherlands
        • MCH Westeinde
      • Dirksland, Netherlands
        • Van Weel-Bethesda Hospital
      • Dordrecht, Netherlands
        • Albert Schweitzer Hospital
      • Helmond, Netherlands
        • Elkerliek Hospital
      • Hoorn, Netherlands
        • Westfriesgasthuis Hoorn
      • Leiden, Netherlands
        • LUMC
      • Maastricht, Netherlands
        • University Hospital Maastricht
      • Nijmegen, Netherlands
        • CWZ Nijmegen
      • Rotterdam, Netherlands
        • Sint Franciscus Gasthuis
      • Rotterdam, Netherlands
        • Maasstad Hospital
      • Schiedam, Netherlands
        • SSVZ
      • Tilburg, Netherlands
        • St. Elisabeth Hospital
    • Zuid Holland
      • Rotterdam, Zuid Holland, Netherlands, 3000 CA
        • Erasmus Medical Center
  • Puerto Rico
      • San Juan, Puerto Rico
        • University of Puerto Rico
  • South Africa
      • Cape Town, South Africa
        • University of Cape Town
  • Spain
      • Barcelona, Spain
        • Hospital de Bellvitge
      • Barcelona, Spain
        • Hospital Santa Creu i Sant Pau
      • Cordoba, Spain
        • Hospital Universitario Reina Sofia
      • Madrid, Spain
        • Hospital Universitario Infanta Sofía
      • Madrid, Spain
        • Clinica Hospital 2 de Octubre
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
      • Pamplona, Spain
        • Complejo Hospitalario de Navarra
      • Santander, Spain
        • Hospital Marqués de Valdecilla
      • Santiago De Compostela, Spain
        • Hospital de Santiago
      • Sevilla, Spain
        • Hospital Virgen de Sevilla
  • Switzerland
      • Bern, Switzerland, 3010
        • Universityhospital Bern, Inselspital
      • Fribourg, Switzerland, 1708
        • HFR - Cantonal Hospital
      • Geneva, Switzerland, 1205
        • Hôpitaux Universitaires de Genève
      • Lausanne, Switzerland, 1011
        • Lausanne University Hospital
      • Lugano, Switzerland, 6900
        • Ospeale Civico Lugano
      • Sion, Switzerland
        • Hopital du Valais
      • St. Gallen, Switzerland, 9007
        • Kantonspital St. Gallen
  • Taiwan
      • Tai Pei, Taiwan
        • National Taiwan University Hospital
  • United Kingdom
      • Birmingham, United Kingdom
        • Queen Elizabeth Hospital
      • Bradford, United Kingdom
        • Bradford Royal Infirmary
      • Cambridge, United Kingdom
        • Addenbrooke's Hospital
      • Edinburgh, United Kingdom
        • Western General Hospital
      • Glasgow, United Kingdom
        • University of Glasgow
      • Huntingdon, United Kingdom
        • Hinching Brooke Hospital
      • Larbert, United Kingdom
        • NHS Forth Valley Hospital
      • Leeds, United Kingdom
        • Leeds General Infirmary
      • Liverpool, United Kingdom
        • The Walton Centre
      • London, United Kingdom
        • Charing Cross Hospital
      • London, United Kingdom
        • King's College Hospital
      • London, United Kingdom
        • National Hospital of Neurology and Neurosurgery
      • London, United Kingdom
        • St. George's Hospital
      • Middlesborough, United Kingdom
        • James Cook University Hospital
      • Newcastle, United Kingdom
        • Royal Victoria Infirmary
      • Oxford, United Kingdom
        • University of Oxford
      • Sheffield, United Kingdom
        • Royal Hallamshire Hospital
      • Wakefield, United Kingdom
        • Pinderfields Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrows Neurological Institute
    • California
      • Orange, California, United States, 92868
        • UC Irvine Health
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School Of Medicine
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
    • Iowa
      • Iowa City, Iowa, United States, 52242-1098
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160-7314
        • University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine
      • Baltimore, Maryland, United States, 21205-1911
        • Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 01805
        • Lahey clinic Boston
      • Boston, Massachusetts, United States, 02135
        • Tufts University School of Medicine
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Spectrum Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson Medical School
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
    • New York
      • Buffalo, New York, United States, 14203
        • University at Buffalo
      • New York, New York, United States, 10032
        • Columbia University
      • New York, New York, United States, 10029-6574
        • Mt. Sinai School of Med
      • New York, New York, United States, 10467
        • Montefiore MC
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Wexner Medical Center at the Ohio State University
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • University of Tennessee
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah School of Medicine
    • Vermont
      • Burlington, Vermont, United States, 05405
        • University of Vermont College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
GBS
Guillain-Barré syndrome >1000, follow-up 1-3 years
NC
Normal controls (NC)
IC
Infectious controls (IC)
OND
Other neurological diseases (OND)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Guillain Barré Syndrome (GBS) disability score
Time Frame: 1 year
7 scores for disability, ranging from a healthy state to dead; 0 = healthy state to 6 = dead
1 year
MRC sum score
Time Frame: 1 year
the sum of MRC scores of six muscle groups, including shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and foot dorsiflexors on both sides, ranging from 60 (normal) to 0 (quadriplegic). 0 = no visible contraction to 5 = normal strength, score per muscle group
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Neuropathy Limitations Scale (ONLS)
Time Frame: 1 year
Questions regarding affection of ability in both arms and legs, with a score from 0 = normal to 5 = disability in both arms preventing all purposeful movements and a score from 0 = walking/climbing stairs/running not affected to 7 = restricted to wheelchair or bed most of the day, unable to make any purposeful movements of the legs
1 year
Fatigue Severity Scale (FSS)
Time Frame: 1 year
the FSS is a simple and reliable instrument to assess and quantify fatigue for clinical and research purposes.
1 year
EurQol EQ-5D Health Questionnaire
Time Frame: 1 year
EQ-5D® is a standardized instrument for use as a measure of health outcome with a scale from 0 = the worst health you can imagine to 100 = the best health you can imagine
1 year
Rasch-built Overall Disability Scale (R-ODS)
Time Frame: one year
The R-ODS is a linearly weighted scale that specifically captures activity and social participation limitations in patients with GBS, CIDP, and MGUSP. Compared to the Overall Disability Sum Score, the R-ODS represents a wider range of item difficulties, thereby better targeting patients with different ability levels. If responsive, the R-ODS will be valuable for future clinical trials and follow-up studies in these conditions. Score from 0 = not possible to perform any activity to 48 = easy to perform any activity
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Investigators

  • Principal Investigator: Bart Jacobs, Dr., Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

April 20, 2012

First Submitted That Met QC Criteria

April 20, 2012

First Posted (Estimate)

April 23, 2012

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-2011-477
  • 3290 (Other Identifier: Dutch Trial Registration)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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