Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06005844
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2023-08-07
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
Sponsor:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Organization:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCASS-FR
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 scales 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
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 scales 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
1 To determine the other accuracy measures for version 1A of the French CCAS scale
2 To determine the performance indices ie 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 patients 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 ie blind to hisher colleagues rating patients responses without directly interfering in the administration of the scale
The choice of alternative version ie 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
1 To determine the other accuracy measures for version 1A of the French CCAS scale
2 To determine the performance indices ie 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 patients 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 ie blind to hisher colleagues rating patients responses without directly interfering in the administration of the scale
The choice of alternative version ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None