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

Retention Disorders, Cognitive Clinical Trial

— MMS-LS  

Official title:

Transposition of the Mini-Mental State in Sign Language

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005679
• Other study ID #: RC-P0008
• Status: Completed
• Phase: N/A
• Start date: June 17, 2011
• Est. completion date: December 7, 2017

Study information

• Verified date: February 2019
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: December 7, 2017
• Est. primary completion date: December 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Memory Disorders
• Prelingual Deafness
• Retention Disorders, Cognitive

Intervention

Behavioral:
• application of the mini-mental state test

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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