Cerebellar Cognitive-affective SyndromeCCASS-FRNCT06005844
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
A study testing Cerebellar Cognitive-Affective Syndrome Scale in people with Cerebellar Cognitive-affective Syndrome, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebellar Cognitive-affective Syndrome
- What is being tested?
- Cerebellar Cognitive-Affective Syndrome Scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
GHRMSA
Mulhouse, Haut-Rhin, 68100
Thomas Palpacuer, MD, +33389646464, thomas.palpacuer@[chez]ghrmsa.fr
About this study
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).
Read the 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..
- Conditions
- Cerebellar Cognitive-affective Syndrome
- Being tested
- Cerebellar Cognitive-Affective Syndrome Scale
- Keywords
- Schmahmann syndrome, Cerebellar cognitive-affective syndrome, Screening
- Medical subject headings
- Cerebellar Cognitive Affective Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebellar Cognitive-Affective Syndrome ScaleDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Adults with a cerebellar damage | Other | Not described Receives: Diagnostic Test: Cerebellar Cognitive-Affective Syndrome Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the 1A French version of the cerebellar cognitive-affective syndrome scale
Measured: Up to 7 days
Secondary outcomes (7)
Specificity of the 1A French version of the cerebellar cognitive-affective syndrome scale
Measured: Up to 7 days
Sensitivity and specificity of the 1B, 1C and 1D French versions of the cerebellar cognitive-affective syndrome scale
Measured: 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.
Measured: 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
Measured: 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
Measured: Day 1
Time to complete version 1A of the French scale
Measured: Day 1
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.
Measured: Up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start9 Nov 2023
- Primary completionOct 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar Cognitive-affective SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 217 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005844
- Sponsor's protocol ID
- GHRMSA 1228
- Acronym
- CCASS-FR
- Status last verified
- May 2025
- First submitted
- 7 Aug 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06005844
- Acronym / sponsor ID
- CCASS-FR / GHRMSA 1228
- Conditions
- Cerebellar Cognitive-affective Syndrome
- Keywords
- Schmahmann syndrome, Cerebellar cognitive-affective syndrome, Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 217 participants (estimated)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with a cerebellar damage | Other | Diagnostic Test: Cerebellar Cognitive-Affective Syndrome Scale |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebellar Cognitive-Affective Syndrome ScaleThe 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. | Diagnostic test | Adults with a cerebellar damage |
Primary outcome
Sensitivity of the 1A French version of the cerebellar cognitive-affective syndrome scale
Time frame: Up to 7 days
7 secondary outcomes
Specificity of the 1A French version of the cerebellar cognitive-affective syndrome scale
Time frame: Up to 7 days
Sensitivity and specificity of the 1B, 1C and 1D French versions of the cerebellar cognitive-affective syndrome scale
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Day 1
Time to complete version 1A of the French scale
Time frame: Day 1
Total raw score on version 1A at V3
Time frame: Up to 100 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebellar Cognitive-Affective Syndrome Scale in people with Cerebellar Cognitive-affective Syndrome, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the 1A French version of the cerebellar cognitive-affective syndrome scale (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.