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

Small Vessel Cerebrovascular Disease Clinical Trial

— SMACS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04170673
• Other study ID #: APHP190597
• Status: Recruiting
• Start date: December 15, 2019
• Est. completion date: December 15, 2022

Study information

• Verified date: November 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Sophie TEZENAS DU MONTCEL
• Phone: +33142160582
• Email: sophie.tezenas[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases
• Cerebrovascular Disorders
• Small Vessel Cerebrovascular Disease

Locations

Country	Name	City	State
France	Lariboisiere hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Intra evaluator reliability		3 years post-inclusion
Secondary	Inter-evaluator reliability		3 years post-inclusion
Secondary	Scale validity		3 years post-inclusion
Secondary	Scale sensitivity to change	To determine clinically important minimal difference.	3 years post-inclusion