ClinicalTrials.gov record NCT07099651
Autosomal Dominant Spinocerebellar Ataxias and Social Cognition
Ataxies SpinoCérébelleuses Autosomiques Dominantes et Cognition Sociale - Etude SoCoSca
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This study compares people with genetically confirmed autosomal dominant spinocerebellar ataxia (SCA1, 2, 3, 6, 7, 27B) and healthy controls. Participants complete a battery of social-cognition and emotion-recognition tests and have brain MRI. The goal is to describe social-cognitive performance and how it relates to brain imaging, disease duration, and ataxia severity.
What it is studying. Whether people with these genetically confirmed SCA subtypes show differences in emotion recognition and cognitive and affective theory-of-mind on both standard and more ecologically valid dynamic/interactive tests, and how any differences relate to brain MRI findings, disease duration, and clinical severity.
What the researchers hope to learn. Describe and quantify social-cognition and emotion-recognition performance in SCA patients; identify pathological thresholds on these tests; compare different SCA subtypes and clinical presentations; examine correlations between social-cognition measures and brain MRI, disease duration, ataxia severity, and motor function.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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 being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- tests
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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)
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants complete a session of neuropsychological and social-cognition testing: emotion-recognition tasks, theory-of-mind tasks (including video-based tests), a social problem-solving task with some role-playing, and questionnaires about behavior and mood. They will also do brief motor tests (Box and Block, Nine-Hole Peg) and undergo magnetic resonance imaging (MRI); some imaging measures are scheduled up to about 3 months. Some tests involve watching videos and interacting with a partner; the registry does not list invasive procedures.
How the study is structured. Non-randomized, parallel-group interventional study with two arms (patients with autosomal dominant SCA and healthy controls). No masking. Participants undergo neuropsychological test sessions (several social-cognition and emotion-recognition tasks) and brain magnetic resonance imaging (MRI). Assessments are used for baseline comparisons and correlation analyses between tests, imaging, and clinical measures.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on spinocerebellar ataxia
Important dates
- Study start
- Dec 9, 2025
- Primary completion
- Nov 1, 2028 (estimated)
- Study completion
- Jan 1, 2029 (estimated)
- Target enrollment
- 160 participants (estimated)
- Last updated on registry
- Jul 20, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University Hospital, Angers
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Philippe Allain, professor 📞 +33241355976 ✉ phallain@chu-angers.fr
Participating sites (1)
- CHU AngersRecruiting
Angers, 49933 · France
- Philippe ALLAIN, Professor · +332 41 35 55 46
Terms used on this page · explanations by MedicalUpdates.ai
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- contraindications
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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