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

• Conditions: Small Vessel Cerebrovascular Disease

• Registration Number: NCT04170673
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-20
• Study Start: 2019-12-15
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-07
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lariboisiere hospital; 🇫🇷 Paris, France