An observational study in Small Vessel Cerebrovascular Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
374 studies on the registry are indexed under Cerebrovascular Disorders; 129 are open to participants now.
This study's planned enrollment of 150 is below the median of 443 across 135 observational studies indexed under Cerebrovascular Disorders.
Browse Cerebrovascular Disorders studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with small vessel disease will be recruited from the Department of Neurology at Lariboisière Hospital. The study will be proposed to patients when they come to Lariboisière Hospital for hospitalization (full hospitalization or day hospitalization) or consultation.
Optional:
Exclusion Criteria:
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
Time frame: 3 years post-inclusion
Internal validity of each scale
To analyze correlations between items, scale structure, o floor and ceiling effects and profiles of missing data
Time frame: 3 years post-inclusion
Intra evaluator reliability
Time frame: 3 years post-inclusion
Inter-evaluator reliability
Time frame: 3 years post-inclusion
Scale validity
Time frame: 3 years post-inclusion
Scale sensitivity to change
To determine clinically important minimal difference.
Time frame: 3 years post-inclusion
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris