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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • GHRMSA

    Mulhouse, Haut-Rhin, 68100

    Thomas Palpacuer, MD, +33389646464, thomas.palpacuer@[chez]ghrmsa.fr

    Recruiting

Other trials in France

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:

  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..
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 groups in NCT06005844
Study groupRoleWhat they receive
Adults with a cerebellar damageOtherNot 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.

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

    Measured: Up to 7 days

Secondary outcomes (7)
  1. Specificity of the 1A French version of the cerebellar cognitive-affective syndrome scale

    Measured: Up to 7 days

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

    Measured: Up to 7 days

  3. 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

  4. 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

  5. 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

  6. Time to complete version 1A of the French scale

    Measured: Day 1

  7. 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.

  1. First posted23 Aug 2023
  2. Study start9 Nov 2023
  3. Primary completionOct 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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)
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

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.

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