Development of a Global Scale Assessing Impairment in Cerebral Small Vessel Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Develop a Global Clinical Severity Scale in Patients with cerebral SVD
研究概览
简要总结
In daily practice, several scales are used to evaluate patients with small vessel diseases of the brain (SVD). However, these scales exclude key symptoms such as apathy and mood disorders observed in SVD. Furthermore, the use of a combination of scales does not allow neither a very sensitive assessment of clinical changes, neither an overall assessment of a patient's outcome.
Moreover, there is no scale dedicated to cognitive, emotional and behavioural complaints in patients with SVD. These patients are evaluated with scales used in neurodegenerative diseases such as Alzheimer's disease and frontotemporal dementia. These are scales that have been developed in the elderly and they are not sensitive to minor complaints. It is needful to develop scales adapted to patients with SVD in order to understand the consequences of the disease symptoms on their daily life at inclusion and during follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •French mother language
- •French reading and writing
- •The patient can fulfil the questionnaire on his own, without any help.
- •Brain imaging suggestive of SVD: confluent white matter hypersignals with symmetric distribution, small deep infarction, cerebral haemorrhage, microbleeds
- •Presence of informative companion in contact with the patient at least once every 15 days
排除标准
- •Presence of unacquired cognitive impairment (mental retardation, developmental disorders)
- •Presence of non-vascular leukoencephalopathy
- •Clinical picture and evolution suggesting a degenerative disease
- •Serious or unstable psychiatric problems (psychoses, severe depression)
- •Unstable clinical status
结局指标
主要结局
Develop a Global Clinical Severity Scale in Patients with cerebral SVD
时间窗: 3 years post-inclusion
The primary outcome is to develop this scale, thus precise definition of the scale is not available
次要结局
- Internal validity of each scale(3 years post-inclusion)
- Scale sensitivity to change(3 years post-inclusion)
- Intra evaluator reliability(3 years post-inclusion)
- Inter-evaluator reliability(3 years post-inclusion)
- Scale validity(3 years post-inclusion)