International Guillain-Barré Syndrome Outcome Study
- Conditions
- Guillain-Barré SyndromeMiller Fisher Syndrome
- Registration Number
- NCT01582763
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2000
- 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
- There are no exclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Guillain Barré Syndrome (GBS) disability score 1 year 7 scores for disability, ranging from a healthy state to dead; 0 = healthy state to 6 = dead
MRC sum score 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
- Secondary Outcome Measures
Name Time Method Overall Neuropathy Limitations Scale (ONLS) 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
Rasch-built Overall Disability Scale (R-ODS) 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
EurQol EQ-5D Health Questionnaire 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
Fatigue Severity Scale (FSS) 1 year the FSS is a simple and reliable instrument to assess and quantify fatigue for clinical and research purposes.
Trial Locations
- Locations (138)
Barrows Neurological Institute
🇺🇸Phoenix, Arizona, United States
UC Irvine Health
🇺🇸Orange, California, United States
Yale University School of medicine
🇺🇸New Haven, Connecticut, United States
University of Florida
🇺🇸Jacksonville, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Lahey clinic Boston
🇺🇸Boston, Massachusetts, United States
Tufts University School of Medicine
🇺🇸Boston, Massachusetts, United States
Spectrum Health System
🇺🇸Grand Rapids, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
University at Buffalo
🇺🇸Buffalo, New York, United States
Columbia University
🇺🇸New York City, New York, United States
Mt. Sinai School of Med
🇺🇸New York, New York, United States
Montefiore MC
🇺🇸New York, New York, United States
Wexner Medical Center at The Ohio State University
🇺🇸Columbus, Ohio, United States
University of Tennessee
🇺🇸Memphis, Tennessee, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
The university of Texas Health Science Center
🇺🇸Houston, Texas, United States
University of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States
University of Vermont College of Medicine
🇺🇸Burlington, Vermont, United States
Hospital Austral
🇦🇷Buenos Aires, Argentina
Hospital Britanico
🇦🇷Buenos Aires, Argentina
Hospital Cesar Milstein
🇦🇷Buenos Aires, Argentina
Hospital de Clinicas
🇦🇷Buenos Aires, Argentina
Hospital Fleni
🇦🇷Buenos Aires, Argentina
Hospital Garrahan
🇦🇷Buenos Aires, Argentina
Hospital Militar
🇦🇷Buenos Aires, Argentina
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Concord Repatriation General Hospital Sydney
🇦🇺Sydney, Australia
Dhaka Medical College & Hospital
🇧🇩Dhaka, Bangladesh
ICDDR,B
🇧🇩Dhaka, Bangladesh
Clinique Universitaire St. Luc
🇧🇪Brussels, Belgium
University Hospital Leuven
🇧🇪Leuven, Belgium
University of Calgary
🇨🇦Calgary, Canada
Queens University
🇨🇦Kingston, Canada
University hospital LHSC
🇨🇦London, Canada
University Health Network
🇨🇦Toronto, Canada
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Xiang Hospital Central South University
🇨🇳Changsha, Hunan, China
The affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Affiliated Hospital of Jining Medical University
🇨🇳Jining, Shandong, China
Aalborg Hospital
🇩🇰Aalborg, Denmark
Aarhus University Hospital
🇩🇰Aarhus, Denmark
National Hospital Copenhagen
🇩🇰Copenhagen, Denmark
Glostrup Hospital Copenhagen
🇩🇰Glostrup, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Hospital de la Timone
🇫🇷Marseille, France
Nantes University Hospital
🇫🇷Nantes, France
Hôpital St. Louis de Paris
🇫🇷Paris, France
University Strassbourg
🇫🇷Strasbourg, France
Universitätsklinikum der RWTH
🇩🇪Aachen, Germany
University of Cologne
🇩🇪Cologne, Germany
Universitatsklinikum Dresden
🇩🇪Dresden, Germany
Heinrich Heine University
🇩🇪Duesseldorf, Germany
University Hospital of Saarland
🇩🇪Homburg, Germany
Universitatsklinikum Würzburg
🇩🇪Würzburg, Germany
University of Thessaly
🇬🇷Larissa, Thessaly, Greece
University of Genova
🇮🇹Genova, Italy
Ospedale Sant'Andrea La Spezia
🇮🇹la Spezia, Italy
Ospedale Luigi Sacco
🇮🇹Milan, Italy
Ospedale San Raffaele
🇮🇹Milan, Italy
University of Milan
🇮🇹Milan, Italy
University of Modena
🇮🇹Modena, Italy
University of Milano-Bicocca
🇮🇹Monza, Italy
Universita FedericoII di Napoli
🇮🇹Napoli, Italy
University of Padova
🇮🇹Padova, Italy
Policlinico Tor Vergata
🇮🇹Roma, Italy
Erasmus Medical Center
🇳🇱Rotterdam, Zuid Holland, Netherlands
AMC Amsterdam
🇳🇱Amsterdam, Netherlands
Gelre ziekenhuis
🇳🇱Apeldoorn, Netherlands
Sant' Andrea Hospital
🇮🇹Rome, Italy
Chiba University School of Medicine
🇯🇵Chiba, Japan
Hokkaido Medical Center
🇯🇵Sapporo, Japan
Dokkyo Medical Univeristy
🇯🇵Tochigi, Japan
National Defense Medical College
🇯🇵Tokorozawa, Japan
Toho University Medical Center
🇯🇵Tokyo, Japan
University of Malaya
🇲🇾Kuala Lumpur, Malaysia
Kinki University School of Medicine
🇯🇵Osaka, Japan
Rode Kruis Ziekenhuis
🇳🇱Beverwijk, Netherlands
Reinier de Graaf Groep
🇳🇱Delft, Netherlands
Jeroen Bosch Ziekenhuis
🇳🇱Den Bosch, Netherlands
HAGA ziekenhuis
🇳🇱Den Haag, Netherlands
MCH Westeinde
🇳🇱Den Haag, Netherlands
Van Weel-Bethesda Hospital
🇳🇱Dirksland, Netherlands
Albert Schweitzer Hospital
🇳🇱Dordrecht, Netherlands
Elkerliek hospital
🇳🇱Helmond, Netherlands
Westfriesgasthuis Hoorn
🇳🇱Hoorn, Netherlands
LUMC
🇳🇱Leiden, Netherlands
University Hospital Maastricht
🇳🇱Maastricht, Netherlands
CWZ Nijmegen
🇳🇱Nijmegen, Netherlands
Maasstad Hospital
🇳🇱Rotterdam, Netherlands
Sint Franciscus Gasthuis
🇳🇱Rotterdam, Netherlands
SSVZ
🇳🇱Schiedam, Netherlands
University of Puerto Rico
🇵🇷San Juan, Puerto Rico
St. Elisabeth hospital
🇳🇱Tilburg, Netherlands
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain
University of Cape Town
🇿🇦Cape Town, South Africa
Hospital de Bellvitge
🇪🇸Barcelona, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Spain
Hospital Marques de Valdecilla
🇪🇸Santander, Spain
Hospital de Santiago
🇪🇸Santiago De Compostela, Spain
Hospital Virgen de Sevilla
🇪🇸Sevilla, Spain
Hospital Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Clinica Hospital 2 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Infanta Sofia
🇪🇸Madrid, Spain
Universityhospital Bern, Inselspital
🇨🇭Bern, Switzerland
HFR - Cantonal Hospital
🇨🇭Fribourg, Switzerland
Hôpitaux Universitaires de Genève
🇨🇭Geneva, Switzerland
Lausanne University Hospital
🇨🇭Lausanne, Switzerland
Ospeale Civico Lugano
🇨🇭Lugano, Switzerland
Hopital du Valais
🇨🇭Sion, Switzerland
National Taiwan University Hospital
🇨🇳Tai Pei, Taiwan
Kantonspital St. Gallen
🇨🇭St. Gallen, Switzerland
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
University of Glasgow
🇬🇧Glasgow, United Kingdom
Hinching Brooke Hospital
🇬🇧Huntingdon, United Kingdom
NHS Forth Valley Hospital
🇬🇧Larbert, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
The Walton Centre
🇬🇧Liverpool, 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
🇬🇧London, United Kingdom
James Cook University Hospital
🇬🇧Middlesborough, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle, United Kingdom
University of Oxford
🇬🇧Oxford, United Kingdom
Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Pinderfields Hospital
🇬🇧Wakefield, United Kingdom