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Recruiting NCT07099651

Autosomal Dominant Spinocerebellar Ataxias and Social Cognition

No phase Interventional Autosomal Dominant Spinocerebellar Ataxia (SCA1, 2,3,6,7,27B)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tests.
Who it may be relevant to
Registry conditions: Autosomal Dominant Spinocerebellar Ataxia (SCA1, 2,3,6,7,27B). Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Ataxies SpinoCérébelleuses Autosomiques Dominantes et Cognition Sociale - Etude SoCoSca

Overview

Spinocerebellar ataxias are a group of rare neurodegenerative diseases, clinically and genetically highly heterogeneous, with an estimated mean prevalence of 2.7 per 100,000 population. The term "spinocerebellar ataxia" or "SCA" is often used for ataxias of genetic origin of autosomal dominant transmission, which are the subject of this study. Recent studies of social cognition in patients with genetic cerebellar pathologies, and autosomal dominant spinocerebellar ataxia in particular, are still few and far between (around 15 studies), and seem to highlight impairment of basic emotion recognition and theory of mind skills. That said, data have very often been collected on very small samples of patients (sometimes in case study format). They also remain contradictory, including in the examination of the cerebellar anatomoclinical correlates of the deficits. Thus, the question arises as to whether patients with spinocerebellar ataxia also show impairments in emotion recognition and cognitive and affective theory of mind in more ecologically valid dynamic and interactive assessment situations.

Interventions

  • Other tests
    neuropsychological tests + Neuroimaging

Primary outcome measures

  • to assess the social cognition with the Facial Emotion Recognition Test from classical approach [Time frame: Baseline]
  • to assess the social cognition with the Faux Pas Test from classical approach [Time frame: Baseline]
  • to assess the social cognition with the Reading the Mind in the Eyes test from classical approach [Time frame: Baseline]
  • to assess the social cognition with the sequencing test from classical approach [Time frame: Baseline]
  • to assess the social cognition with the French Emotion Evaluation Test from ecological approach [Time frame: Baseline]
  • to assess the social cognition with the Movie for the Assessment of Social Cognition Test from ecological approach [Time frame: Baseline]
  • to assess the social cognition with the social problem-solving test from interactionist approach [Time frame: Baseline]
Secondary outcome measures (12)
  • Search for and describe any deficits in social cognition by identifying pathological treshold with Facial Emotion Recognition Test [Time frame: Baseline]
  • Research and describe any deficits in social cognition by identifying pathological treshold with false step test [Time frame: Baseline]
  • Research and describe any deficits in social cognition by identifying pathological treshold with Reading the Mind in the Eyes test [Time frame: Baseline]
  • Search for and describe any deficits in social cognition by identifying pathological treshold with sequencing test [Time frame: Baseline]
  • Research and describe any deficits in social cognition by identifying pathological treshold with French Emotion Evaluation Test [Time frame: Baseline]
  • Research and describe any deficits in social cognition by identifying pathological treshold with Movie for the Assessment of Social Cognition [Time frame: Baseline]
  • Research and describe any deficits in social cognition by identifying pathological treshold with social problem-solving test [Time frame: Baseline]
  • Research and describe any deficits in social cognition by identifying pathological treshold with brain neuroimaging [Time frame: 3 months]
  • Study correlations between social cognition efficiency and - Global cognitive functioning assessed by the CCAS-S scale [Time frame: Baseline]
  • Study correlations between social cognition efficiency and Sociobehavioral and emotional abilities assessed by the Neuropsychiatric Inventory Questionnaire [Time frame: Baseline]
  • Study correlations between social cognition efficiency and Sociobehavioral and Sociobehavioral and emotional abilities assessed by the Frontal System Behaviour Scale [Time frame: Baseline]
  • Study correlations between social cognition efficiency and Sociobehavioral and Sociobehavioral by Hospital Anxiety and Depression scale [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

For all participants:

  • Men or women aged 18 and over
  • At least 7 years' schooling (CEP level)
  • Ability to read, write and speak French
  • Signed informed consent to participate in the study

For patients :

\- With molecularly confirmed autosomal dominant spinocerebellar ataxia (SCA1, 2, 3, 6, 7, 27B)

For controls:

\- With no neurological pathology (questioning and neurological examination)

Exclusion criteria

For patients and controls:

  • Simultaneous participation in another protocol that may interfere with the measurement of the criteria of interest
  • Physical or cultural factors likely to interfere with test performance
  • History likely to interfere with cognition (stroke, cranioencephalic trauma, other neurodegenerative disease, epilepsy, learning disability, alcohol dependence syndrome, psychiatric disorders...)
  • Persons with contraindications to MRI scans
  • Pregnant, nursing or parturient women
  • Persons deprived of their liberty by judicial or administrative decision
  • Persons under compulsory psychiatric care
  • Persons subject to a legal protection measure
  • Persons unable to express their consent
  • Persons not affiliated to or not benefiting from a social security scheme (beneficiary or beneficiary entitled)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU Angers — Angers

Identifiers

NCT: NCT07099651 · 49RC23_0390 · ID-RCB 2025-A01253-46

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗