Autosomal Dominant Spinocerebellar Ataxias and Social Cognition (NCT07099651) | Clinical Trial Compass
RecruitingNot Applicable
Autosomal Dominant Spinocerebellar Ataxias and Social Cognition
France160 participantsStarted 2025-12-09
Plain-language summary
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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
to assess the social cognition with the Facial Emotion Recognition Test from classical approach
Timeframe: Baseline
2
to assess the social cognition with the Faux Pas Test from classical approach
Timeframe: Baseline
3
to assess the social cognition with the Reading the Mind in the Eyes test from classical approach
Timeframe: Baseline
4
to assess the social cognition with the sequencing test from classical approach
Timeframe: Baseline
5
to assess the social cognition with the French Emotion Evaluation Test from ecological approach
Timeframe: Baseline
6
to assess the social cognition with the Movie for the Assessment of Social Cognition Test from ecological approach
Timeframe: Baseline
7
to assess the social cognition with the social problem-solving test from interactionist approach