Clinical trial NCT02005679: Mini-Mental State (MMS-LS) and Sign Language
Official title: Transposition of the Mini-Mental State in Sign Language
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prelingual Deafness
Retention Disorders, Cognitive
Keywords: Prelingual Deafness
Retention Disorders, Cognitive
Sign language
Mini-Mental State
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: At baseline, 1 year and 2 years follow-up visits
Secondary outcomes:
measure: Description of MMS-LS test results
timeFrame: Baseline
measure: Diagnostic performance and predictive values of MMS-LS test for acquired dementia.
timeFrame: Baseline, 1 year and 2 years follow-up visits
measure: Correlation between MMS-LS score and CDR level
timeFrame: Baseline, 1 year and 2 years follow-up visits
measure: Diagnostic performance and predictive values of MMS-LS test for suspected dementia.
timeFrame: Baseline, 1 year and 2 years follow-up visits
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital de la Conception, Pôle psychiatrie Centre
state: Bouches-du-Rhône
city: Rennes
country: France
facility: CHU de Rennes, Hôpital de Pontchaillou
state: Ille-et-Vilaine
city: Nancy
country: France
facility: Unité Régionale d'Accueil et de Soins pour Sourds et malentendants - CHRU Nancy
state: Meurthe-et-Moselle
city: Lille
country: France
facility: Groupement des Hôpitaux de l'Institut Catholique de Lille
state: Nord Pas De Calais
Study officials:
affiliation: 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
name: Benoît Drion, MD
role: STUDY_DIRECTOR
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille, Medical Research Department
name: Amélie Lansiaux, MD
role: STUDY_CHAIR
affiliation: CHU de Rennes, Hôpital de Pontchaillou
name: Isabelle Ridoux, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital de la Conception, Pôle psychiatrie, Marseille
name: Corine Gilda Scemama-Ammar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille
name: Charlotte Crinquette, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU de Nancy, Unité Régionale d'Accueil et de Soins pour Sourds et malentendants
name: Isabelle Bouillevaux, MD
role: PRINCIPAL_INVESTIGATOR
References: