The Social-HD Study: A Cross-Sectional Observational Study of Social Cognition in Early Huntington Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Significant difference in mean value of "Double Movie for the Assessment of Social Cognition-Multiple Choice" (DMASC-MC) total score between HD and controls
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Huntington disease
Participants with early Huntington disease
Controls
Participants with no heritage of HD or negative pre-symptomatic HD gene test
结局指标
主要结局
Significant difference in mean value of "Double Movie for the Assessment of Social Cognition-Multiple Choice" (DMASC-MC) total score between HD and controls
时间窗: Baseline
To investigate if persons with HD have a significantly lower score than a control group in the test "Double Movie for the Assessment of Social Cognition-Multiple Choice" (DMASC-MC)". DMASC-MC: Minimum value 0, maximum value 44, higher scores mean a better outcome.
次要结局
- Significant difference in mean value of Reading the Mind in the Eyes Test (RMET) total score between HD and controls(Baseline)
- Significant difference in mean value of Emotional Hexagon Test (EHT) total score between HD and controls(Baseline)
- Significant correlation between social cognitive test scores and Montreal Cognitive Assessment (MOCA) scores(Baseline)
- Significant correlation between social cognitive test scores and total functional capacity (TFC) scores(Baseline)
- Significant correlation between social cognitive test scores and CAG-Age-Product (CAP) scores(Baseline)
- Significant correlation between social cognitive test scores and total motor scores (TMS).(Baseline)
- Significant correlation between social cognitive test scores and Montgomery-Åsberg Depression Rating Scale (MADRS) scores(Baseline)
- Significant correlation between social cognitive test scores and apathy evaluation scale (AES) scores(Baseline)
- Significant correlation between social cognitive test scores and cognitive scores(Baseline)
- Proportion of both HD subjects and control subjects with impaired results on each of the social cognitive tests, compared to norms.(Baseline)