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

A

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Small Vessel Cerebrovascular Disease

Study type

Observational

Funder types

Other

Identifiers

NCT04170673
APHP190597

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Matthieu Resche-Rigon; Sophie TEZENAS DU MONTCEL

Data sourced from clinicaltrials.gov

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