Trial document





This trial has been registered retrospectively.
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  DRKS00016854

Trial Description

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Title

Validation of German versions of the "Cerebellar Cognitive Affective Syndrome" Scale in patients with degenerative and focal cerebellar disorders.

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Trial Acronym

German CCAS Scales

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URL of the Trial

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Brief Summary in Lay Language

Traditionally, motor signs are associated with cerebellar disorders. These signs include difficulties in standing and walking as well as trembling, imprecise limb movements. Besides, disturbed eye movements and a slurring speech can be observed in cerebellar patients. During the recent two to three decades cognitive (this means processes associated with thinking) and affective (this means processes associated with mood) deficits have been shown to be apparent in patients with cerebellar disorders as well. Particularly, problems with executive functions have been described in patients. These are important, for example, for the short-term memory, in planning tasks, and in organization and execution of complex cognitive (thinking) tasks. Furthermore, speech can be disturbed, especially the finding of words in a conversation. Moreover, tasks that require spatial imagination cause difficulties in patients compared to healthy individuals. Finally, the regulation of emotion and mood is impaired in patients. Already in 1998, this complex of symptoms was summarized as “Cerebellar Cognitive Affective Syndrome (= CCAS)" (Schmahmann and Sherman, 1998). To date, diagnosis relied on extensive neuropsychological testing which is not practicable in the clinical daily routine because of the enormous binding of time and specially trained personnel. A short screening instrument, like established in diagnosing dementia (e.g. Mini Mental State Examination; MMSE), has been missing so far. Schmahmann and collaborators have recently developed an according bedside test (CCAS Scale) for cerebellar patients (Hoche et al. 2018). It has been validated in English-speaking adults with cerebellar disorders. It has been shown that the CCAS Scale is a reliable tool to diagnose the CCAS and that the scale can well distinguish between patients and healthy individuals. Till now, the CCAS Scale is only available in English. Three additional alternative versions B - D have also been developed by the Schmahmann group enabling repeated applications of the scale and avoiding training effects. According German test versions have been missing so far. The aim of this study is to validate four German versions (A-D) of the CCAS Scale. We have translated the four English versions to German together with colleagues in Bonn and Tübingen. Now we want to examine if the German versions of the scale work as well as the English versions.

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Brief Summary in Scientific Language

Traditionally, motor symptoms are associated with cerebellar disorders which are called “ataxias”. These symptoms include difficulties in standing and walking as well as trembling, imprecise arbitrary limb movements. Besides, disturbed eye movements and a slurring, incomprehensible speech can be observed in cerebellar patients. During the recent two to three decades cognitive and affective deficits have been shown to be apparent in patients with cerebellar disorders as well. Particularly, problems with executive functions which are important, for example, for the short-term memory, in planning tasks, and in organization and execution of complex cognitive tasks, have been described. Furthermore, higher functions of speech are disturbed, especially the finding of words. Moreover, tasks that presume spatial imagination cause difficulties in patients compared to healthy subjects. Finally, the regulation of emotion and affect is impaired in cerebellar patients. Already in 1998, this complex of symptoms was summarized as “Cerebellar Cognitive Affective Syndrome (= CCAS)" (Schmahmann and Sherman, 1998). To date, diagnosis relied on extensive neuropsychological testing which is not practicable in the clinical daily routine because of the enormous binding of time and specially trained personnel. A short screening instrument, like established in diagnosing dementia (e.g. Mini Mental State Examination; MMSE), has been missing so far. Schmahmann and collaborators have recently developed an according bedside test (CCAS Scale) for cerebellar patients (Hoche et al. 2018). It has been validated in an English-speaking cohort of adult cerebellar patients and showed high values both for sensitivity and specificity in diagnosing the CCAS. Till now, the CCAS Scale is only available in English. Three additional alternative versions B - D have also been developed by the Schmahmann group enabling repeated applications of the scale and avoiding training effects. According German test versions have been missing so far. The aim of this study is to validate four German versions (A-D) of the CCAS Scale. We have translated the four English versions to German together with colleagues in Bonn and Tübingen and will now validate these versions in patients with different cerebellar disorders.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00016854
  •   2019/03/01
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  •   yes
  •   Approved
  •   18-8444-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   degenerative ataxias, focal cerebellar lesions after hemorrhage, ischaemic stroke, tumor or surgery on/in the cerebellum
  •   I63 -  Cerebral infarction
  •   R27.0 -  Ataxia, unspecified
  •   G11 -  Hereditary ataxia
  •   D33 -  Benign neoplasm of brain and other parts of central nervous system
  •   C71 -  Malignant neoplasm of brain
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Interventions/Observational Groups

  •   degenerative ataxias: application of the following scales/assessments:

    I. CCAS Scale version A, B, C or D.
    In a subgroup of patients testing with one version of the scale twice
    a) by the same examiner (determination of the re-test-reliability)
    b) by different examiners (determination of the interrater-reliability)
    c) additional extensive neuropsychological testing (determination of the construct-validity)

    II. SARA, ICARS, INAS, SCAFI, BARS (determination of the severity of the motor symptoms)

    III. Edinburgh-Handedness-Inventory (determination of the handedness)
  •   focal cerebellar lesions after hemorrhage, ischaemic stroke, tumor oder surgery on/in the cerebellums: application of the following scales/assessments:

    I. CCAS Scale version A, B, C or D.
    In a subgroup of patients testing with one version of the scale twice
    a) by the same examiner (determination of the re-test-reliability)
    b) by different examiners (determination of the interrater-reliability)
    c) additional extensive neuropsychological testing (determination of the construct-validity)

    II. SARA, ICARS, INAS, SCAFI, BARS (determination of the severity of the motor symptoms)

    III. Edinburgh-Handedness-Inventory (determination of the handedness)

    IV. cMRT in a subgroup of patients (correlation of cognitive deficits to cerebellar lesions using lesion-symptom-mapping)
  •   healthy control subjects: application of the following scales/assessments:

    I. CCAS Scale version A, B, C or D.
    In a subgroup of healthy controls testing with one version of the scale twice
    a) by the same examiner (determination of the re-test-reliability)
    b) by different examiners (determination of the interrater-reliability)
    c) additional extensive neuropsychological testing (determination of the construct-validity)

    II. SARA, ICARS, INAS, SCAFI, BARS (determination of the severity of the motor symptoms; control group)

    III. Edinburgh-Handedness-Inventory (determination of the handedness)

    IV. cMRT in a subgroup of controls (control group; correlation of cognitive deficits to cerebellar lesions using lesion-symptom-mapping in patients)
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Characteristics

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

Validation of the versions A-D of the German CCAS Scale.

After data acquisition the following parameters are determined for this purpose:

- re-test-reliability
- interrater-reliability
- parallel-test-reliability
- internal consistency
- construct-validity
- sensitivity
- specifity

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Secondary Outcome

1. Pattern of cognitive/affective deficits in different cerebellar disorders
2. Correlation of cognitive/affective deficits in patients with focal cerebellar lesions to lesion sites shown by MRI (lesion-symptom-mapping) in following trials

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/01/25
  •   600
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1. Written consent.
2. Minimum age 18 years.
3. German-speaking.

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Exclusion Criteria

1. Healthy control subjects: Neurological disorders (inclusive epileptic seizures) or psychiatric conditions.
2. Patients: Severe psychiatric conditions.
3. Drug or alcohol abuse.
4. Intake of centrally acting drugs.
5. Persons with consuming disorders and in reduced general health condition.
6. (Adult) persons that have a legal guardian and that are not contractually capable.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Neurologische Klinik, Universitätsklinikum Essen
    • Ms.  Prof. Dr. med.  Dagmar  Timmann-Braun 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Neurologische Klinik, Universitätsklinikum Essen
    • Mr.  Dr. med.  Andreas  Gustafsson Thieme 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Neurologische Klinik, Universitätsklinikum Essen
    • Mr.  Dr. med.  Andreas  Gustafsson Thieme 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Ethikvotum
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* This entry means the parameter is not applicable or has not been set.