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CompletedNCT02005679MMS-LSUpdated Feb 15, 2019

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

An interventional study of application of the mini-mental state test in Prelingual Deafness and Retention Disorders, Cognitive, sponsored by Lille Catholic University. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Lille Catholic University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jun 2011, registered Nov 2013).
Phase
Not applicable
Study type
Interventional
Enrollment
195
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Prelingual Deafness
  • Retention Disorders, Cognitive

Keywords

  • Prelingual Deafness
  • Retention Disorders, Cognitive
  • Sign language
  • Mini-Mental State
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In context

Deafness

609 studies on the registry are indexed under Deafness; 111 are open to participants now.

This study's enrollment of 195 is above the median of 40 across 411 interventional studies indexed under Deafness.

Browse Deafness studies →

Lead sponsor

Lille Catholic University is the lead sponsor of 111 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
195 participants (actual)

Study arms

  • Experimental
    deaf persons with potential dementia

    Behavioral: application of the mini-mental state test

Interventions

  • Behavioralapplication of the mini-mental state test
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What researchers measure

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

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

    Time frame: Baseline

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

    Sensitivity, specificity, positive and negative predictive values.

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

  3. Correlation between MMS-LS score and CDR level

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

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

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

    Sensitivity, specificity, positive and negative predictive values

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

07

Study locations

4 sites
  • Hôpital de la Conception, Pôle psychiatrie Centre
    Marseille, Bouches-du-Rhône 13885, France
  • CHU de Rennes, Hôpital de Pontchaillou
    Rennes, Ille-et-Vilaine 35000, France
  • Unité Régionale d'Accueil et de Soins pour Sourds et malentendants - CHRU Nancy
    Nancy, Meurthe-et-Moselle 54000, France
  • Groupement des Hôpitaux de l'Institut Catholique de Lille
    Lille, Nord Pas De Calais 59962, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02005679
Lead sponsor
Lille Catholic University
Responsible party
Sponsor
First posted
Dec 9, 2013
Start date
Jun 17, 2011
Primary completion
Dec 7, 2017
Completion
Dec 7, 2017
Last update
Feb 15, 2019

Study contacts

Benoît Drion, MD
study director · Groupement des Hôpitaux de l'Institut Catholique de Lille, Unité d'Accueil et de Soins des Sourds en Langue des Signes et Réseau Sourds et Santé
Amélie Lansiaux, MD
study chair · Groupement des Hôpitaux de l'Institut Catholique de Lille, Medical Research Department
Isabelle Ridoux, MD
principal investigator · CHU de Rennes, Hôpital de Pontchaillou
Corine Gilda Scemama-Ammar, MD
principal investigator · Hôpital de la Conception, Pôle psychiatrie, Marseille
Charlotte Crinquette, MD
principal investigator · Groupement des Hôpitaux de l'Institut Catholique de Lille
Isabelle Bouillevaux, MD
principal investigator · CHRU de Nancy, Unité Régionale d'Accueil et de Soins pour Sourds et malentendants

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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