Evaluation of Three Tests to Assess Social Cognition in Huntington Disease
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Huntington Disease. Basic parameters: 18 years — 75 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
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Social-HD Study: A Cross-Sectional Observational Study of Social Cognition in Early Huntington Disease
Overview
The goal of this observational study is to learn about the usefulness of a test of social functioning in persons with Huntington disease. Huntington disease affects motor function, psychological well-being and cognitive functions ("thinking abilities" such as paying attention, remembering and solving problems). It is also believed to affect important social functions, including the ability to understand others' intentions and emotions (social cognition). The test of interest in this study is called The Double Movie for the Assessment of Social Cognition-Multiple Choice (DMASC-MC) and will be compared to two other similar and well-known tests. The main question which the study aims to answer is: • Is DMASC-MC a useful tool for detecting problems with social functioning in adult persons with early Huntington disease? In the study, participants will meet with a medical doctor and a psychologist for assessment of different symptoms related to Huntington disease, including social functioning. Better methods for identifying problems with social functioning could help persons with Huntington disease and their families in mainly two ways. Firstly, it could increase their understanding of how the disease has affected them. Secondly, a better understanding of these problems could lead to better recommendations and interventions from medical teams, which would also benefit persons with Huntington disease and families.
Detailed description
Background:
Huntington disease (HD) is a fatal neurodegenerative disorder that leads to motor disturbances, psychiatric symptoms and dementia. It is caused by an expanded CAG repeat in the huntingtin (HTT) gene which is inherited in an autosomal dominant fashion with full penetrance. It typically manifests in midlife. There are no disease-modifying therapies and current care is focused on reducing symptoms and improving quality of life. An important understudied part of the clinical manifestation is the early development of personality changes that have major impact on most aspects of the life of the affected person. These changes may be due to altered social cognition. Today, assessment of social cognition is often not part of the neuropsychological battery for HD and the so far investigated tests may not capture sufficient aspects of altered social cognition.
Aim:
The aim is to investigate whether the social cognitive test "Double Movie for the Assessment of Social Cognition-Multiple Choice (DMASC-MC) " will detect a significant difference in persons with early stages of HD compared to age and sex matched controls.
Methods:
This clinical research study will include 20 persons with early HD and 20 matched controls. The number of participants is based on a power calculation. The research participants will be assessed using DMASC-MC as well as two other tests for social cognition, Reading the Mind in the Eyes Test and The Emotion Hexagon Test. They will also be evaluated for typical cognitive deficits, psychiatric symptoms and motor aspects in HD.
Relevance:
This study aims to bridge an important gap in clinical care where evaluation of social cognition is not yet part of standard assessments. Determination of social cognitive deficits will be important for planning care and facilitate communication for HD families.
Primary outcome measures
- Significant difference in mean value of "Double Movie for the Assessment of Social Cognition-Multiple Choice" (DMASC-MC) total score between HD and controls [Time frame: Baseline]
Secondary outcome measures (10)
- Significant difference in mean value of Reading the Mind in the Eyes Test (RMET) total score between HD and controls [Time frame: Baseline]
- Significant difference in mean value of Emotional Hexagon Test (EHT) total score between HD and controls [Time frame: Baseline]
- Significant correlation between social cognitive test scores and Montreal Cognitive Assessment (MOCA) scores [Time frame: Baseline]
- Significant correlation between social cognitive test scores and total functional capacity (TFC) scores [Time frame: Baseline]
- Significant correlation between social cognitive test scores and CAG-Age-Product (CAP) scores [Time frame: Baseline]
- Significant correlation between social cognitive test scores and total motor scores (TMS). [Time frame: Baseline]
- Significant correlation between social cognitive test scores and Montgomery-Åsberg Depression Rating Scale (MADRS) scores [Time frame: Baseline]
- Significant correlation between social cognitive test scores and apathy evaluation scale (AES) scores [Time frame: Baseline]
- Significant correlation between social cognitive test scores and cognitive scores [Time frame: Baseline]
- Proportion of both HD subjects and control subjects with impaired results on each of the social cognitive tests, compared to norms. [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
Inclusion criteria for persons with HD
- Clinical diagnosis of HD
- CAG repeat: 40 and more
Inclusion criteria for control group
1\. No heritage of HD or negative pre-symptomatic HD gene test
Exclusion criteria
Participants in both groups are excluded from the study if any of the following criteria apply:
- Dementia or MOCA<19, The Mini Mental State Examination (MMSE) <19
- Other neurological disorders
- Ongoing psychosis
- Ongoing alcohol/drug addiction
- Other native language than Swedish
- Severe problems with vision and hearing
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Sweden · 1 center
- Skane University Hospital, Region Skane — Lund
Identifiers
NCT: NCT07253038 · 2025-04424-01