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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 (CCASS-FR)

Primary Purpose

Cerebellar Cognitive-affective Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cerebellar Cognitive-Affective Syndrome Scale
Sponsored by
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cerebellar Cognitive-affective Syndrome focused on measuring Schmahmann syndrome, Cerebellar cognitive-affective syndrome, Screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria : French speaking Acquired lesion or predominantly degenerative cerebellar pathology of any etiology Affiliated or beneficiary of a social security scheme Written informed consent Non-inclusion criteria: History or progressive pathology of the central nervous system other than cerebellar disease Chronic ethylic patient with active consumption, or alcohol withdrawal of less than three months Use of other toxic substances Blind or severely visually impaired patient Deaf or severely hearing-impaired patient unable to understand instructions Mute patient Patient deprived of liberty or under legal protection Secondary exclusion criteria : - Patients with incomplete French scale and/or neuropsychological assessment will be replaced.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Adults with a cerebellar damage

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Specificity of the 1A French version of the cerebellar cognitive-affective syndrome scale
    Sensitivity and specificity of the 1B, 1C and 1D French versions of the cerebellar cognitive-affective syndrome scale
    Sensitivity and specificity measured on the different versions of CCASS when a positive result is defined by ≥ 2 or ≥ 3 failed subtests respectively.
    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
    Inter-rater agreement measured on the total raw score of the different versions of the French scale by calculating the intraclass correlation coefficient and using the Bland and Altman method
    Time to complete version 1A of the French scale
    Total raw score on version 1A at V3
    The learning effect will be assessed in the subgroup of patients included at Mulhouse hospital. Comparison of the total raw score on version 1A at V1 and the total raw score on version 1A at V3 will be performed.

    Full Information

    First Posted
    August 7, 2023
    Last Updated
    August 16, 2023
    Sponsor
    Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06005844
    Brief Title
    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
    Acronym
    CCASS-FR
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 25, 2023 (Anticipated)
    Primary Completion Date
    September 25, 2026 (Anticipated)
    Study Completion Date
    February 25, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).
    Detailed Description
    Secondary objectives: To determine the other accuracy measures for version 1A of the French CCAS scale; To determine the performance indices (i.e., sensitivity, specificity) of French versions 1B, 1C and 1D of CCAS scale; To determine the performance indices of versions 1A, 1B, 1C, and 1D of CCAS scale when positivity is defined by ≥ 2 or ≥ 3 failed subtests, respectively; To evaluate the consistency of results from versions 1B, 1C and 1D compared with version 1A; To assess the inter-rater reliability of the different versions of the French scale; To assess the learning effect on version 1A of the French scale in the subgroup of patients included at Mulhouse hospital; To measure the time taken by patients to complete version 1A of the French scale. Conduct of research: The study will take place in the following french centers: GHRMSA - Hôpital Emile Muller (Mulhouse), AP-HP - Hôpital Pitié-Salpêtrière (Paris), CHRU Nancy - Hôpital Central (Nancy), Hôpitaux civils de Colmar (Colmar). - V0 Screening: The protocol will be proposed to all eligible patients by the investigator. - V1 Inclusion visit and CCASS test: The inclusion visit will be scheduled on the date of the patient's next follow-up medical appointment. 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, without directly interfering in the administration of the scale. The choice of alternative version (i.e., 1B, 1C, or 1D) will be randomized. - V2 Gold standard: Within 7 days of completing CCASS, a complete neuropsychological assessment will be carried out by a third neuropsychologist, blinded to the results of the scale. - V3 Re-testing of version 1A of CCASS: In the subgroup of patients included at Mulhouse hospital, a second administration of version 1A of CCASS will be carried out by one of the two neuropsychologists who carried out the V1 visit. V3 will be scheduled 80 to 100 days after V1..

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebellar Cognitive-affective Syndrome
    Keywords
    Schmahmann syndrome, Cerebellar cognitive-affective syndrome, Screening

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    217 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Adults with a cerebellar damage
    Arm Type
    Other
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Cerebellar Cognitive-Affective Syndrome Scale
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Sensitivity of the 1A French version of the cerebellar cognitive-affective syndrome scale
    Time Frame
    Up to 7 days
    Secondary Outcome Measure Information:
    Title
    Specificity of the 1A French version of the cerebellar cognitive-affective syndrome scale
    Time Frame
    Up to 7 days
    Title
    Sensitivity and specificity of the 1B, 1C and 1D French versions of the cerebellar cognitive-affective syndrome scale
    Time Frame
    Up to 7 days
    Title
    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
    Title
    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
    Title
    Inter-rater agreement measured on the total raw score of the different versions of the French scale by calculating the intraclass correlation coefficient and using the Bland and Altman method
    Time Frame
    Day 1
    Title
    Time to complete version 1A of the French scale
    Time Frame
    Day 1
    Title
    Total raw score on version 1A at V3
    Description
    The learning effect will be assessed in the subgroup of patients included at Mulhouse hospital. Comparison of the total raw score on version 1A at V1 and the total raw score on version 1A at V3 will be performed.
    Time Frame
    Up to 100 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria : French speaking Acquired lesion or predominantly degenerative cerebellar pathology of any etiology Affiliated or beneficiary of a social security scheme Written informed consent Non-inclusion criteria: History or progressive pathology of the central nervous system other than cerebellar disease Chronic ethylic patient with active consumption, or alcohol withdrawal of less than three months Use of other toxic substances Blind or severely visually impaired patient Deaf or severely hearing-impaired patient unable to understand instructions Mute patient Patient deprived of liberty or under legal protection Secondary exclusion criteria : - Patients with incomplete French scale and/or neuropsychological assessment will be replaced.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    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

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