Trial document




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  DRKS00006140

Trial Description

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Title

Ultrasound in the early stage of Guillain-Barré syndrome

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Trial Acronym

GBS-US

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URL of the Trial

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Brief Summary in Lay Language

Guillain-Barré syndrome (GBS) is a dangerous and under certain circumstances life-threatening polyneuropathy of acute onset. Patients usually present with distal onset of slight sensory symptoms such as numbness and tingling followed by ascending weakness of arms and legs, often involving cranial nerves. Diagnostic consists out of clinical examination, laboratory Analysis including cerebrospinal fluid and electrodiagnostic studies.
Sometimes diagnosis is difficult and challenging and therapy is delayed.
Ultrasound of the peripheral nerve System seems to be able to detect nerve inflammation. Therefore, aim of our study was to prove, whether acute GBS-patients show ultrasonic detectable nerve alterations comparable to electrodiagnostic findings and whether this method could help diagnosing patients with GBS in the very early phase of disease.

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Brief Summary in Scientific Language

Guillain-Barré syndrome (GBS) is a dangerous and under certain circumstances life-threatening polyneuropathy of acute onset. Patients usually present with distal onset of slight sensory symptoms such as numbness and tingling followed by ascending weakness of arms and legs, often involving cranial nerves (Fokke et al., 2014). Typical clinical findings are bilateral, flaccid paresis, reduced or absent deep tendon reflexes and only slight sensory symptoms. Many variants of GBS exist such as pharyngeal-brachial or bulbar variants, the Miller-Fisher syndrome (MFS) with ataxia, areflexia and oculomotor dysfunction or the Elsberg syndrome with accentuated involvement of autonomic nerve system. Diagnosis of GBS is normally based on typical clinical onset, laboratory findings and electrophysiological studies (Asbury and Cornblath, 1990; Hadden et al., 1998; Fokke et al., 2014). CSF-analysis reveals elevated CSF protein without or with only slight increased CSF cell count (<50/µL), so-called cyto-albuminological dissociation. The course is monophasic and onset-nadir is reached at week 4. Therapy usually consists of intravenous immunoglobulin or plasma exchange.
Sometimes – especially in early phase of disease - diagnosis can be challenging in cases of asymmetric involvement, preserved deep tendon reflexes, primarily sensory symptoms. Also CSF-analysis can be normal and cyto-albuminological dissociation is found in less than a half of patients, especially in early stages (Fokke et al. 2014). However, early treatment is important and most effective. Also monitoring of sometimes life-threatening autonomic disorders makes immediate diagnosis necessary.
Peripheral nerve ultrasound and its role in neuropathies - especially in the immune-mediated polyneuropathies such as CIDP, MADSAM and MMN - is well described in literature (Beekman et al., 2005; Zaidman et al., 2009 and 2013, Padua et al. 2012 and 2013; Scheidl et al., 2012 and 2014; Hobson-Webb et al., 2013 and 2014; Kerasnoudis, 2013; Kerasnoudis et al., 2013 and 2014a; Grimm et al., 2014). In post-GBS patients persistent nerve enlargement has recently been reported (Kerasnoudis et al., 2013b). However, a correlation to clinical severity or to electrophysiological findings is denied. For the subacute phase of GBS only a case report of an 8 year old child and small case-series are available (Almeida et al., 2012 and Kerasnoudis et al., 2014b). Therefore, aim of our study was to prove, whether acute GBS-patients show ultrasonic detectable nerve alterations comparable to electrodiagnostic findings and whether this method could help diagnosing patients with GBS in the very early phase of disease.

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Organizational Data

  •   DRKS00006140
  •   2014/05/08
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  •   yes
  •   Approved
  •   3663-01/13, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

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Health Condition or Problem studied

  •   G61.0 -  Guillain-Barré syndrome
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Interventions/Observational Groups

  •   Patients with Guillain-Barré syndrome day 1-3 after first symptoms or clinical stay (ultrasound of the nerves and neurography)
  •   Healthy controls (ultrasound of the nerves and neurography)
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Blinded
  •   assessor
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Differences concerning cross sectional area of peripheral nerves using ultrasound between both groups

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Secondary Outcome

Correlation between clinical course and nerve cross sectional area

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Countries of Recruitment

  •   Germany
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/05/12
  •   20
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Patients with suspected Guillain-Barre-Syndrome

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Exclusion Criteria

none

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Hans Berger Department of Neurology Jena University Hospital Friedrich-Schiller-University Jena Germany
    • Mr.  Dr.  Alexander Grimm  Grimm 
    • Erlanger Allee 101
    • D-07747  Jena
    • Germany
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    • Hans Berger Department of Neurology Jena University Hospital Friedrich-Schiller-University Jena Germany
    • Mr.  Dr.  Alexander Grimm  Grimm 
    • Erlanger Allee 101
    • D-07747  Jena
    • Germany
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    • Hans Berger Department of Neurology Jena University Hospital Friedrich-Schiller-University Jena Germany
    • Mr.  Dr.  Alexander Grimm  Grimm 
    • Erlanger Allee 101
    • D-07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsspital Basel und Universitätsklinikum JenaErlanger Alleee 101, 07747 Jena
    • Mr.  Dr.   Alexander Grimm 
    • 07747  Jena
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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