Clinical trial NCT04170673: Development of a Global Scale Assessing Impairment in Cerebral Small Vessel Diseases
Official title: Development of a Global Scale Assessing Impairment in Cerebral Small Vessel Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Small Vessel Cerebrovascular Disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Develop a Global Clinical Severity Scale in Patients with cerebral SVD
timeFrame: 3 years post-inclusion
Secondary outcomes:
measure: Internal validity of each scale
timeFrame: 3 years post-inclusion
measure: Intra evaluator reliability
timeFrame: 3 years post-inclusion
measure: Inter-evaluator reliability
timeFrame: 3 years post-inclusion
measure: Scale validity
timeFrame: 3 years post-inclusion
measure: Scale sensitivity to change
timeFrame: 3 years post-inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Lariboisiere hospital
Study officials:
References: