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

Transposition of the Mini-Mental State in 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.

Study Overview

• Status: Completed
• Conditions: Prelingual Deafness; Retention Disorders, Cognitive
• Intervention / Treatment: Behavioral: application of the mini-mental state test

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.

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: deaf persons with potential dementia	Behavioral: application of the mini-mental state test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	At baseline, 1 year and 2 years follow-up visits

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline
Diagnostic performance and predictive values of MMS-LS test for acquired dementia.	Sensitivity, specificity, positive and negative predictive values.	Baseline, 1 year and 2 years follow-up visits
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.	Baseline, 1 year and 2 years follow-up visits
Diagnostic performance and predictive values of MMS-LS test for suspected dementia.	Sensitivity, specificity, positive and negative predictive values	Baseline, 1 year and 2 years follow-up visits

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Study Director: Benoît Drion, MD, 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; Study Chair: Amélie Lansiaux, MD, Groupement des Hôpitaux de l'Institut Catholique de Lille, Medical Research Department; Principal Investigator: Isabelle Ridoux, MD, CHU de Rennes, Hopital de Pontchaillou; Principal Investigator: Corine Gilda Scemama-Ammar, MD, Hôpital de la Conception, Pôle psychiatrie, Marseille; Principal Investigator: Charlotte Crinquette, MD, Groupement des Hôpitaux de l'Institut Catholique de Lille; Principal Investigator: Isabelle Bouillevaux, MD, CHRU de Nancy, Unité Régionale d'Accueil et de Soins pour Sourds et malentendants

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2011
• Primary Completion (Actual): December 7, 2017
• Study Completion (Actual): December 7, 2017

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Prelingual Deafness; Retention Disorders, Cognitive; Sign language; Mini-Mental State
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Memory Disorders
• Other Study ID Numbers: RC-P0008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No