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NCT Number: NCT02005679

Mini-Mental State (MMS-LS) and Sign Language

In France the prevalence of pre-lingual deafness is between 1 and 1.4 per 1000 habitants, and according to very conservative estimates, about 44 000 deaf persons use the sign language. Additionally, the prevalence of dementia in France is close to 1% (850 000 dements for a total population of 65 millions). The prevalence of dementia in pre-lingual deaf adults has also been described and is between 1 and 1.4 /100 000 habitants.

The Mini Mental State Examination (MMSE) of Folstein is a test recommended to perform the cognitive evaluation for the detection of mental disorders including dementia, and a consensual French version exists prepared by GRECO (Group of Research and Cognitive Assessments). However, to date, there are no simple, rapid and validated screening tests to study cognitive disorders in deaf persons who use the sign language. The only tests available allow a late diagnosis avoiding an optimal treatment of the patients.

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Key information

Conditions

Prelingual Deafness Behavior Communication Deafness Ear Diseases Hearing Disorders Hearing Loss Language Manual Communication Memory Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nonverbal Communication Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Retention Disorders, Cognitive Sensation Disorders Sign Language Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de la Conception, Pôle psychiatrie Centre, Marseille, Bouches-du-Rhône, France

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About this study

The objective of this study is to assess the intrinsic quality of the tool MMS-LS, a mini-mental state examination that has been adapted to the sign language in order to monitor cognitive disorders in deaf people who speak sign language.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults> 18 years
  • Pre-lingual deafness
  • Use of French sign language

Exclusion criteria

  • Refusal to sign the consent
  • Severe visual impairment with lower acuity (less than 0.5)
  • Severe motor difficulties impeding the practice of sign language

Treatment and study plan

application of the mini-mental state test

Behavioral

Primary outcomes

  1. Assessment of internal consistency of MMS-LS test for the diagnosis of cognitive impairment among deaf patients by a correlation analysis followed by Cronbach's alpha test

    Time frame: At baseline, 1 year and 2 years follow-up visits

Secondary outcomes

  1. Description of MMS-LS test results

    Time frame: Baseline

    Explanatory Factors are: age, education level, characteristics of the sign language(fluency level, learning age, usage frequency, usage by other family members)

  2. Diagnostic performance and predictive values of MMS-LS test for acquired dementia.

    Time frame: Baseline, 1 year and 2 years follow-up visits

    Sensitivity, specificity, positive and negative predictive values.

  3. Correlation between MMS-LS score and CDR level

    Time frame: Baseline, 1 year and 2 years follow-up visits

    We also check that patients having a suspicious CDR (0.5) have a superior MMS-LS score compared to patients having a CDR ≥ 1.

  4. Diagnostic performance and predictive values of MMS-LS test for suspected dementia.

    Time frame: Baseline, 1 year and 2 years follow-up visits

    Sensitivity, specificity, positive and negative predictive values

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

Transposition of the Mini-Mental State in Sign Language

Acronym: MMS-LS

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2013
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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