Validation of the Performance of the French Version of the Cerebellar Cognitive-Affective Syndrome Scale (CCASS) as a Screening Test for Cerebellar Cognitive-affective Syndrome: a National Multicenter Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGroupe Hospitalier de la Region de Mulhouse et Sud Alsace

About this trial

The primary objective of the study is to assess the performance of the French version of the Cerebellar Cognitive-Affective Syndrome Scale (CCASS) as a screening test for cerebellar cognitive-affective syndrome.

The primary endpoint will be the sensitivity of version 1A of the French scale. The result will be considered positive if the patient fails at least one of the scale's subtests. The diagnosis of a cerebellar cognitive-affective syndrome will be made on the basis of a pathological score in the executive, language, visuospatial or psychoaffective domains of the neuropsychological evaluation (gold standard).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

French speaking

Acquired lesion or predominantly degenerative cerebellar pathology of any etiology

Affiliated or beneficiary of a social security scheme

Written informed consent

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Cerebellar Cognitive-Affective Syndrome Scale

    Diagnostic test

    The CCASS will be administered by a neuropsychologist starting with version 1A. An alternative version (1B, 1C or 1D) will also be administered. An interval of approximately 30 minutes should be observed between the two administrations. In order to assess the inter-rater reliability of the scale, a second neuropsychologist will be present in the room and will independently evaluate (i.e., blind to his/her colleague's rating) patient's responses. The choice of alternative version (i.e., 1B, 1C, or 1D) will be randomized.

Treatment groups

217 Participants
are divided into 1 treatment group
Group A: Adults with a cerebellar damageOther 1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity of the 1A French version of the cerebellar cognitive-affective syndrome scale

Time frame
Up to 7 days

Secondary outcomes

1

Specificity of the 1A French version of the cerebellar cognitive-affective syndrome scale

Time frame
Up to 7 days
2

Sensitivity and specificity of the 1B, 1C and 1D French versions of the cerebellar cognitive-affective syndrome scale

Time frame
Up to 7 days
3

Sensitivity and specificity measured on the different versions of CCASS when a positive result is defined by ≥ 2 or ≥ 3 failed subtests respectively.

Time frame
Up to 7 days
4

Concordance between the total raw score of version 1A and the total raw score of versions 1B, 1C, 1D, evaluated graphically using the Bland and Altman method

Time frame
Day 1

Other outcomes

Sponsors and contacts

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