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International Guillain-Barré Syndrome Outcome Study (IGOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01582763
Recruitment Status : Active, not recruiting
First Posted : April 23, 2012
Last Update Posted : February 22, 2023
Sponsor:
Information provided by (Responsible Party):
Dr. B.C. Jacobs, Erasmus Medical Center

Study Description
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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.


Condition or disease
Guillain-Barré Syndrome Miller Fisher Syndrome

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 Design
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Study Type : Observational
Actual Enrollment : 2000 participants
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).
Actual Study Start Date : May 1, 2012
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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


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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582763


Locations
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Sponsors and Collaborators
Erasmus Medical Center
Investigators
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Principal Investigator: Bart Jacobs, Dr. Erasmus Medical Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.

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Responsible Party: Dr. B.C. Jacobs, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01582763    
Other Study ID Numbers: MEC-2011-477
3290 ( Other Identifier: Dutch Trial Registration )
First Posted: April 23, 2012    Key Record Dates
Last Update Posted: February 22, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Dr. B.C. Jacobs, Erasmus Medical Center:
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
Additional relevant MeSH terms:
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Guillain-Barre Syndrome
Miller Fisher Syndrome
Syndrome
Disease
Pathologic Processes
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Autoimmune Diseases
Immune System Diseases
Post-Infectious Disorders
Chronic Disease
Disease Attributes
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases