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

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.

Study Overview

• Status: Unknown
• Conditions: Small Vessel Cerebrovascular Disease

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Sophie TEZENAS DU MONTCEL; Phone Number: +33142160582; Email: sophie.tezenas@aphp.fr
• Study Contact Backup: Name: Matthieu Resche-Rigon; Phone Number: +33142499742

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Lariboisière Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2019
• Primary Completion (ANTICIPATED): December 15, 2022
• Study Completion (ANTICIPATED): December 15, 2022

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (ACTUAL): November 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Cerebral Small Vessel Diseases
• Other Study ID Numbers: APHP190597

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No