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RecruitingNCT02701036

Sporadic Degenerative Ataxia With Adult Onset: Natural History Study

Sporadic Degenerative Ataxia With Adult Onset: Natural History Study (SPORTAX-NHS)

Sponsor

Ataxia Study Group

Enrollment

300 participants

Start Date

Apr 1, 2010

Study Type

OBSERVATIONAL

Conditions

Late Onset Sporadic Cerebellar Ataxia

Summary

The key goals of SPORTAX-NHS is to compare the phenotype of multiple system atrophy of cerebellar type (MSA-C) and sporadic adult onset ataxia of unknown aetiology (SAOA) and to determine the rate of disease progression in both groups including determination of the factors that predict the development of MSA-C vs. SAOA, and at which time after onset of ataxia, a reliable distinction between both disorders is possible. The planned study will also allow to collect blood samples and other biomaterials from patients with sporadic ataxia, which will be useful for future genetic and biomarker studies.

Eligibility

Min Age: 40 Years

Inclusion Criteria3

  • Progressive ataxia
  • Disease onset after the age of 40 years
  • Informative and negative family history (no similar disorders in first- and second-degree relatives; parents older than 50 years, or, if not alive, age at death of more than 50 years, no consanguinity of parents)

Exclusion Criteria16

  • No established acquired cause of ataxia
  • No onset of ataxia in association with stroke, encephalitis, sepsis, hyperthermia or heat stroke;
  • no chronic diarrhea;
  • no unexplained visual loss;
  • no alcohol abuse;
  • no chronic intake of anticonvulsant drugs;
  • no other toxic causes; no malignancies;
  • no rapid progression (development of severe ataxia in less than 12 weeks);
  • no insulin-dependent diabetes mellitus
  • No evidence of multiple sclerosis, ischemia, hemorrhage or tumor of the posterior fossa;
  • absence of signal abnormalities on T2/FLAIR-images except abnormalities compatible with MSA
  • Negative molecular genetic testing for FRDA (only required if there is no cerebellar atrophy on MRI, SCA1, SCA2, SCA3, SCA6, FMR1 premutation (only required if prominent tremor, cognitive impairment and signal abnormality on T2/FLAIR images in the middle cerebellar peduncle);
  • antineuronal antibodies negative (only required, if disease duration less than 3 years);
  • normal levels of vitamin B12;
  • VDRL negative;
  • normal thyreoid function

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Locations(14)

Department of Neurology, Medical University, Innsbruck

Innsbruck, Austria

Universitätsmedizin Berlin Charité

Berlin, Germany

Department of Neurology, University of Bonn

Bonn, Germany

Department of Neurology, University Clinic Essen, University of Duisburg-Essen

Essen, Germany

Department of Neurology, University of Frankfurt

Frankfurt, Germany

Hamburg UKE Abt. Neuropädiatrie

Hamburg, Germany

Otto-von-Guericke Universität Magdeburg

Magdeburg, Germany

Friedrich-Baur-Institut an der Neurologischen Klinik

München, Germany

Universitätsmedidzin Rostock - Klinik und Poliklinik für Neurologie

Rostock, Germany

Dept. of Neurodegenerative Diseases Tübingen

Tübingen, Germany

Department of Neuroscience, Federico II University Naples

Naples, Italy

Universita cattolica del sacro cuore

Rome, Italy

Radboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition, and Behaviour

Nijmegen, Netherlands

Oslo University Hospital

Oslo, Norway

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NCT02701036