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

NCT04170673 | Unknown

• 1 other identifier: APHP190597
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Vessel Cerebrovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Internal validity of each scale

  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

  3 years post-inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Lariboisiere hospital

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Sophie TEZENAS DU MONTCEL

CONTACT

+33142160582; sophie.tezenas@aphp.fr

Matthieu Resche-Rigon

CONTACT

+33142499742

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: December 15, 2019
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: July 7, 2020

Record last verified: 2019-11

Locations

FR (1)