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

NCT ID: NCT04170673

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-15

Study Completion Date

2022-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Small Vessel Cerebrovascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lariboisiere hospital

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sophie TEZENAS DU MONTCEL

Role: CONTACT

+33142160582

Matthieu Resche-Rigon

Role: CONTACT

+33142499742

Facility Contacts

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Nathalie GASTELLIER, PhD

Role: primary

149956872 ext. +33

matthieu RESCHE-RIGON, MD-PhD

Role: backup

142499742 ext. +33

Other Identifiers

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APHP190597

Identifier Type: -

Identifier Source: org_study_id

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