xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06005844</url>
    </required_header>
    <id_info>
      <org_study_id>GHR 1228</org_study_id>
      <nct_id>NCT06005844</nct_id>
    </id_info>
    <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</brief_title>
    <acronym>CCASS-FR</acronym>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Groupe Hospitalier de la Region de Mulhouse et Sud Alsace</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Groupe Hospitalier de la Region de Mulhouse et Sud Alsace</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary objective of the study is to assess the performance of the French version of the&#xD;
        Cerebellar Cognitive-Affective Syndrome Scale (CCASS) as a screening test for cerebellar&#xD;
        cognitive-affective syndrome.&#xD;
  &#xD;
        The primary endpoint will be the sensitivity of version 1A of the French scale. The result&#xD;
        will be considered positive if the patient fails at least one of the scale's subtests. The&#xD;
        diagnosis of a cerebellar cognitive-affective syndrome will be made on the basis of a&#xD;
        pathological score in the executive, language, visuospatial or psychoaffective domains of the&#xD;
        neuropsychological evaluation (gold standard).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Secondary objectives:&#xD;
  &#xD;
          1. To determine the other accuracy measures for version 1A of the French CCAS scale;&#xD;
  &#xD;
          2. To determine the performance indices (i.e., sensitivity, specificity) of French versions&#xD;
             1B, 1C and 1D of CCAS scale;&#xD;
  &#xD;
          3. To determine the performance indices of versions 1A, 1B, 1C, and 1D of CCAS scale when&#xD;
             positivity is defined by ≥ 2 or ≥ 3 failed subtests, respectively;&#xD;
  &#xD;
          4. To evaluate the consistency of results from versions 1B, 1C and 1D compared with version&#xD;
             1A;&#xD;
  &#xD;
          5. To assess the inter-rater reliability of the different versions of the French scale;&#xD;
  &#xD;
          6. To assess the learning effect on version 1A of the French scale in the subgroup of&#xD;
             patients included at Mulhouse hospital;&#xD;
  &#xD;
          7. To measure the time taken by patients to complete version 1A of the French scale.&#xD;
  &#xD;
             Conduct of research:&#xD;
  &#xD;
             The study will take place in the following french centers: GHRMSA - Hôpital Emile Muller&#xD;
             (Mulhouse), AP-HP - Hôpital Pitié-Salpêtrière (Paris), CHRU Nancy - Hôpital Central&#xD;
             (Nancy), Hôpitaux civils de Colmar (Colmar).&#xD;
  &#xD;
             - V0 Screening: The protocol will be proposed to all eligible patients by the&#xD;
             investigator.&#xD;
  &#xD;
             - V1 Inclusion visit and CCASS test: The inclusion visit will be scheduled on the date&#xD;
             of the patient's next follow-up medical appointment.&#xD;
  &#xD;
             The CCASS will be administered by a neuropsychologist starting with version 1A. An&#xD;
             alternative version (1B, 1C or 1D) will also be administered. An interval of&#xD;
             approximately 30 minutes should be observed between the two administrations. In order to&#xD;
             assess the inter-rater reliability of the scale, a second neuropsychologist will be&#xD;
             present in the room and will independently evaluate (i.e., blind to his/her colleague's&#xD;
             rating) patient's responses, without directly interfering in the administration of the&#xD;
             scale.&#xD;
  &#xD;
             The choice of alternative version (i.e., 1B, 1C, or 1D) will be randomized.&#xD;
  &#xD;
             - V2 Gold standard: Within 7 days of completing CCASS, a complete neuropsychological&#xD;
             assessment will be carried out by a third neuropsychologist, blinded to the results of&#xD;
             the scale.&#xD;
  &#xD;
             - V3 Re-testing of version 1A of CCASS: In the subgroup of patients included at Mulhouse&#xD;
             hospital, a second administration of version 1A of CCASS will be carried out by one of&#xD;
             the two neuropsychologists who carried out the V1 visit.&#xD;
  &#xD;
             V3 will be scheduled 80 to 100 days after V1..&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 25, 2023</start_date>
    <completion_date type="Anticipated">February 25, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 25, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Sensitivity of the 1A French version of the cerebellar cognitive-affective syndrome scale</measure>
      <time_frame>Up to 7 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Specificity of the 1A French version of the cerebellar cognitive-affective syndrome scale</measure>
      <time_frame>Up to 7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensitivity and specificity of the 1B, 1C and 1D French versions of the cerebellar cognitive-affective syndrome scale</measure>
      <time_frame>Up to 7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensitivity and specificity measured on the different versions of CCASS when a positive result is defined by ≥ 2 or ≥ 3 failed subtests respectively.</measure>
      <time_frame>Up to 7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>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</measure>
      <time_frame>Day 1</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>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</measure>
      <time_frame>Day 1</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to complete version 1A of the French scale</measure>
      <time_frame>Day 1</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total raw score on version 1A at V3</measure>
      <time_frame>Up to 100 days</time_frame>
      <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.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">217</enrollment>
    <condition>Cerebellar Cognitive-affective Syndrome</condition>
    <arm_group>
      <arm_group_label>Adults with a cerebellar damage</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Cerebellar Cognitive-Affective Syndrome Scale</intervention_name>
      <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.</description>
      <arm_group_label>Adults with a cerebellar damage</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria :&#xD;
  &#xD;
            -  French speaking&#xD;
  &#xD;
            -  Acquired lesion or predominantly degenerative cerebellar pathology of any etiology&#xD;
  &#xD;
            -  Affiliated or beneficiary of a social security scheme&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
          Non-inclusion criteria:&#xD;
  &#xD;
            -  History or progressive pathology of the central nervous system other than cerebellar&#xD;
               disease&#xD;
  &#xD;
            -  Chronic ethylic patient with active consumption, or alcohol withdrawal of less than&#xD;
               three months&#xD;
  &#xD;
            -  Use of other toxic substances&#xD;
  &#xD;
            -  Blind or severely visually impaired patient&#xD;
  &#xD;
            -  Deaf or severely hearing-impaired patient unable to understand instructions&#xD;
  &#xD;
            -  Mute patient&#xD;
  &#xD;
            -  Patient deprived of liberty or under legal protection&#xD;
  &#xD;
          Secondary exclusion criteria :&#xD;
  &#xD;
          - Patients with incomplete French scale and/or neuropsychological assessment will be&#xD;
          replaced.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Schmahmann syndrome</keyword>
    <keyword>Cerebellar cognitive-affective syndrome</keyword>
    <keyword>Screening</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06005844
  org study id: GHR 1228
  nct id: NCT06005844
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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).
  Secondary objectives:
  
          1. To determine the other accuracy measures for version 1A of the French CCAS scale;
  
          2. To determine the performance indices (i.e., sensitivity, specificity) of French versions
             1B, 1C and 1D of CCAS scale;
  
          3. 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;
  
          4. To evaluate the consistency of results from versions 1B, 1C and 1D compared with version
             1A;
  
          5. To assess the inter-rater reliability of the different versions of the French scale;
  
          6. To assess the learning effect on version 1A of the French scale in the subgroup of
             patients included at Mulhouse hospital;
  
          7. 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..
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Sensitivity of the 1A French version of the cerebellar cognitive-affective syndrome scale
  time frame: Up to 7 days
  measure: Specificity of the 1A French version of the cerebellar cognitive-affective syndrome scale
  time frame: Up to 7 days
  measure: Sensitivity and specificity of the 1B, 1C and 1D French versions of the cerebellar cognitive-affective syndrome scale
  time frame: Up to 7 days
  measure: 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
  measure: 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
  measure: 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
  measure: Time to complete version 1A of the French scale
  time frame: Day 1
  measure: Total raw score on version 1A at V3
  time frame: Up to 100 days
  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.
  arm group label: Adults with a cerebellar damage
  arm group type: Other
  intervention type: Diagnostic Test
  intervention name: Cerebellar Cognitive-Affective Syndrome Scale
  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.
  arm group label: Adults with a cerebellar damage
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Syndrome
  sharing ipd: No