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

NCT06005844 | Recruiting

• 1 other identifier: GHRMSA 1228
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

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).

Conditions

Cerebellar Cognitive-affective Syndrome

Keywords

Schmahmann syndrome; Cerebellar cognitive-affective syndrome; Screening

Outcome Measures

Primary Outcomes (1)

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

  Up to 7 days

Secondary Outcomes (7)

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

  Up to 7 days

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

  Up to 7 days

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

  Up to 7 days

• 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

  Day 1

• 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

  Day 1

Study Arms (1)

Adults with a cerebellar damage

OTHER

Diagnostic Test: Cerebellar Cognitive-Affective Syndrome Scale

Interventions

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.

Adults with a cerebellar damage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• French speaking
• Acquired lesion or predominantly degenerative cerebellar pathology of any etiology
• Affiliated or beneficiary of a social security scheme
• Written informed consent
• 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

You may not qualify if:

• \- Patients with incomplete French scale and/or neuropsychological assessment will be replaced.

Sponsors & Collaborators

• Groupe Hospitalier de la Region de Mulhouse et Sud Alsace: lead

Study Sites (1)

GHRMSA

Mulhouse, Haut-Rhin, 68100, France

RECRUITING

MeSH Terms

Conditions

Cerebellar Cognitive Affective Syndrome

Condition Hierarchy (Ancestors)

Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 23, 2023
• Study Start: November 9, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)