Development of a Global Scale Assessing Impairment in Cerebral Small Vessel Diseases

Study Overview
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Brief Summary
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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.

Official Title
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Development of a Global Scale Assessing Impairment in Cerebral Small Vessel Diseases

Conditions
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Small Vessel Cerebrovascular Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Optional: • Presence of informative companion in contact with the patient at least once every 15 days Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop a Global Clinical Severity Scale in Patients with cerebral SVD | The primary outcome is to develop this scale, thus precise definition of the scale is not available | 3 years post-inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internal validity of each scale | To analyze correlations between items, scale structure, o floor and ceiling effects and profiles of missing data | 3 years post-inclusion | 
| Intra evaluator reliability |  | 3 years post-inclusion | 
| Inter-evaluator reliability |  | 3 years post-inclusion | 
| Scale validity |  | 3 years post-inclusion | 
| Scale sensitivity to change | To determine clinically important minimal difference. | 3 years post-inclusion |