International Guillain-Barré Syndrome Outcome Study

NCT01582763 | Completed

• 2 other identifiers: MEC-2011-4773290
• Study Type: observational
• Target: 2,000
• Locations: 21 countries
• Sites: 138

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.

Conditions

Guillain-Barré Syndrome; Miller Fisher Syndrome

Keywords

Guillain-Barré syndrome; Polyneuropathy; Autoimmune Diseases; Immune System Diseases; Neuromuscular Diseases; Outcome; Quality of life; Disability; Prognostic Determinants; Treatment; Immunoglobulins; Prognosis; Infections; Anti-ganglioside antibodies; Genetic polymorphisms; Electrophysiology; Cerebrospinal Fluid; Serum

Outcome Measures

Primary Outcomes (2)

• Guillain Barré Syndrome (GBS) disability score

  7 scores for disability, ranging from a healthy state to dead; 0 = healthy state to 6 = dead

  1 year

• MRC sum score

  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 Outcomes (4)

• Overall Neuropathy Limitations Scale (ONLS)

  1 year

• Fatigue Severity Scale (FSS)

  1 year

• EurQol EQ-5D Health Questionnaire

  1 year

• Rasch-built Overall Disability Scale (R-ODS)

  one year

Study Arms (4)

GBS

Guillain-Barré syndrome \>1000, follow-up 1-3 years

NC

Normal controls (NC)

IC

Infectious controls (IC)

OND

Other neurological diseases (OND)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (138)

Barrows Neurological Institute

Phoenix, Arizona, 85013, United States

Location

UC Irvine Health

Orange, California, 92868, United States

Location

Yale University School of medicine

New Haven, Connecticut, 06520, United States

Location

University of Florida

Jacksonville, Florida, 32209, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

University of Iowa

Iowa City, Iowa, 52242-1098, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7314, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins

Baltimore, Maryland, 21205-1911, United States

Location

Lahey clinic Boston

Boston, Massachusetts, 01805, United States

Location

Tufts University School of Medicine

Boston, Massachusetts, 02135, United States

Location

Spectrum Health System

Grand Rapids, Michigan, 49525, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

Mt. Sinai School of Med

New York, New York, 10029-6574, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Montefiore MC

New York, New York, 10467, United States

Location

Wexner Medical Center at The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Tennessee

Memphis, Tennessee, 38104, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

The university of Texas Health Science Center

Houston, Texas, 77030, United States

Location

University of Utah School of Medicine

Salt Lake City, Utah, 84132, United States

Location

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

Hospital Austral

Buenos Aires, Argentina

Location

Hospital Britanico

Buenos Aires, Argentina

Location

Hospital Cesar Milstein

Buenos Aires, Argentina

Location

Hospital de Clinicas

Buenos Aires, Argentina

Location

Hospital Fleni

Buenos Aires, Argentina

Location

Hospital Garrahan

Buenos Aires, Argentina

Location

Hospital Militar

Buenos Aires, Argentina

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Concord Repatriation General Hospital Sydney

Sydney, Australia

Location

Dhaka Medical College & Hospital

Dhaka, Bangladesh

Location

ICDDR,B

Dhaka, Bangladesh

Location

Clinique Universitaire St. Luc

Brussels, Belgium

Location

University Hospital Leuven

Leuven, Belgium

Location

University of Calgary

Calgary, Canada

Location

Queens University

Kingston, Canada

Location

University hospital LHSC

London, Canada

Location

University Health Network

Toronto, Canada

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Xiang Hospital Central South University

Changsha, Hunan, 410000, China

Location

The affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Affiliated Hospital of Jining Medical University

Jining, Shandong, 272001, China

Location

Aalborg Hospital

Aalborg, Denmark

Location

Aarhus University Hospital

Aarhus, Denmark

Location

National Hospital Copenhagen

Copenhagen, Denmark

Location

Glostrup Hospital Copenhagen

Glostrup Municipality, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Hôpital St. Louis de Paris

Paris, Paris, 75016, France

Location

Hospital de la Timone

Marseille, France

Location

Nantes University Hospital

Nantes, France

Location

University Strassbourg

Strasbourg, France

Location

Universitätsklinikum der RWTH

Aachen, Germany

Location

University of Cologne

Cologne, Germany

Location

Universitatsklinikum Dresden

Dresden, Germany

Location

Heinrich Heine University

Düsseldorf, Germany

Location

University Hospital of Saarland

Homburg, Germany

Location

Universitatsklinikum Würzburg

Würzburg, Germany

Location

University of Thessaly

Larissa, Thessaly, Greece

Location

University of Genova

Genova, Italy

Location

Ospedale Sant'Andrea La Spezia

La Spezia, Italy

Location

Ospedale Luigi Sacco

Milan, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

University of Milan

Milan, Italy

Location

University of Modena

Modena, Italy

Location

University of Milano-Bicocca

Monza, Italy

Location

Universita FedericoII di Napoli

Napoli, Italy

Location

University of Padova

Padua, Italy

Location

Policlinico Tor Vergata

Roma, Italy

Location

Sant' Andrea Hospital

Rome, Italy

Location

Chiba University School of Medicine

Chiba, Japan

Location

Kinki University School of Medicine

Osaka, Japan

Location

Hokkaido Medical Center

Sapporo, Japan

Location

Dokkyo Medical Univeristy

Tochigi, Japan

Location

National Defense Medical College

Tokorozawa, Japan

Location

Toho University Medical Center

Tokyo, Japan

Location

University of Malaya

Kuala Lumpur, Malaysia

Location

Erasmus Medical Center

Rotterdam, South Holland, 3000 CA, Netherlands

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

AMC Amsterdam

Amsterdam, Netherlands

Location

Gelre ziekenhuis

Apeldoorn, Netherlands

Location

Rode Kruis Ziekenhuis

Beverwijk, Netherlands

Location

Reinier de Graaf Groep

Delft, Netherlands

Location

Van Weel-Bethesda Hospital

Dirksland, Netherlands

Location

Albert Schweitzer Hospital

Dordrecht, Netherlands

Location

Elkerliek hospital

Helmond, Netherlands

Location

Westfriesgasthuis Hoorn

Hoorn, Netherlands

Location

LUMC

Leiden, Netherlands

Location

University Hospital Maastricht

Maastricht, Netherlands

Location

CWZ Nijmegen

Nijmegen, Netherlands

Location

Maasstad Hospital

Rotterdam, Netherlands

Location

Sint Franciscus Gasthuis

Rotterdam, Netherlands

Location

SSVZ

Schiedam, Netherlands

Location

HAGA ziekenhuis

The Hague, Netherlands

Location

MCH Westeinde

The Hague, Netherlands

Location

St. Elisabeth hospital

Tilburg, Netherlands

Location

University of Puerto Rico

San Juan, Puerto Rico

Location

University of Cape Town

Cape Town, South Africa

Location

Hospital de Bellvitge

Barcelona, Spain

Location

Hospital Santa Creu I Sant Pau

Barcelona, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, Spain

Location

Clinica Hospital 2 de Octubre

Madrid, Spain

Location

Hospital Universitario Infanta Sofia

Madrid, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Spain

Location

Hospital Marques de Valdecilla

Santander, Spain

Location

Hospital de Santiago

Santiago de Compostela, Spain

Location

Hospital Virgen de Sevilla

Seville, Spain

Location

Universityhospital Bern, Inselspital

Bern, 3010, Switzerland

Location

HFR - Cantonal Hospital

Fribourg, 1708, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, 1205, Switzerland

Location

Lausanne University Hospital

Lausanne, 1011, Switzerland

Location

Ospeale Civico Lugano

Lugano, 6900, Switzerland

Location

Kantonspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Hopital du Valais

Sion, Switzerland

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Bradford Royal Infirmary

Bradford, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, United Kingdom

Location

Western General Hospital

Edinburgh, United Kingdom

Location

University of Glasgow

Glasgow, United Kingdom

Location

Hinching Brooke Hospital

Huntingdon, United Kingdom

Location

NHS Forth Valley Hospital

Larbert, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

The Walton Centre

Liverpool, United Kingdom

Location

Charing Cross Hospital

London, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

National Hospital of Neurology and Neurosurgery

London, United Kingdom

Location

St. George's Hospital

London, United Kingdom

Location

James Cook University Hospital

Middlesbrough, United Kingdom

Location

Royal Victoria Infirmary

Newcastle, United Kingdom

Location

University of Oxford

Oxford, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

Pinderfields Hospital

Wakefield, United Kingdom

Location

Related Publications (2)

• Doets AY, Lingsma HF, Walgaard C, Islam B, Papri N, Davidson A, Yamagishi Y, Kusunoki S, Dimachkie MM, Waheed W, Kolb N, Islam Z, Mohammad QD, Harbo T, Sindrup SH, Chavada G, Willison HJ, Casasnovas C, Bateman K, Miller JAL, van den Berg B, Verboon C, Roodbol J, Leonhard SE, Benedetti L, Kuwabara S, Van den Bergh P, Monges S, Marfia GA, Shahrizaila N, Galassi G, Pereon Y, Burmann J, Kuitwaard K, Kleyweg RP, Marchesoni C, Sedano Tous MJ, Querol L, Illa I, Wang Y, Nobile-Orazio E, Rinaldi S, Schenone A, Pardo J, Vermeij FH, Lehmann HC, Granit V, Cavaletti G, Gutierrez-Gutierrez G, Barroso FA, Visser LH, Katzberg HD, Dardiotis E, Attarian S, van der Kooi AJ, Eftimov F, Wirtz PW, Samijn JPA, Gilhuis HJ, Hadden RDM, Holt JKL, Sheikh KA, Karafiath S, Vytopil M, Antonini G, Feasby TE, Faber CG, Gijsbers CJ, Busby M, Roberts RC, Silvestri NJ, Fazio R, van Dijk GW, Garssen MPJ, Straathof CSM, Gorson KC, Jacobs BC; IGOS Consortium. Predicting Outcome in Guillain-Barre Syndrome: International Validation of the Modified Erasmus GBS Outcome Score. Neurology. 2022 Feb 1;98(5):e518-e532. doi: 10.1212/WNL.0000000000013139. Epub 2021 Dec 22.

  PMID: 34937789 DERIVED

• Jacobs BC, van den Berg B, Verboon C, Chavada G, Cornblath DR, Gorson KC, Harbo T, Hartung HP, Hughes RAC, Kusunoki S, van Doorn PA, Willison HJ; IGOS Consortium. International Guillain-Barre Syndrome Outcome Study: protocol of a prospective observational cohort study on clinical and biological predictors of disease course and outcome in Guillain-Barre syndrome. J Peripher Nerv Syst. 2017 Jun;22(2):68-76. doi: 10.1111/jns.12209.

  PMID: 28406555 DERIVED

Related Links

• link to website

Biospecimen

Retention: SAMPLES WITH DNA

serum, cerebrospinal fluid, samples with DNA

MeSH Terms

Conditions

Guillain-Barre Syndrome; Miller Fisher Syndrome; Polyneuropathies; Autoimmune Diseases; Immune System Diseases; Neuromuscular Diseases; Infections

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Peripheral Nervous System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Ocular Motility Disorders; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Bart Jacobs, Dr.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 23, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2024
• Study Completion: December 2, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

US (26); BE (2); PR (1); DK (5); CH (7); IT (11); AR (7); ZA (1); BA (2); MY (1); GB (18); ES (10); TW (1); AU (2); CN (4); JP (6); NL (19); GR (1); DE (6); CA (4); FR (4)