Mini-Mental State (MMS-LS) and Sign Language (MMS-LS)
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|ClinicalTrials.gov Identifier: NCT02005679|
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : February 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Prelingual Deafness Retention Disorders, Cognitive||Behavioral: application of the mini-mental state test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||195 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transposition of the Mini-Mental State in Sign Language|
|Actual Study Start Date :||June 17, 2011|
|Actual Primary Completion Date :||December 7, 2017|
|Actual Study Completion Date :||December 7, 2017|
|Experimental: deaf persons with potential dementia||
Behavioral: application of the mini-mental state test
- 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 ]
- 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)
- 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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005679
|Hôpital de la Conception, Pôle psychiatrie Centre|
|Marseille, Bouches-du-Rhône, France, 13885|
|CHU de Rennes, Hôpital de Pontchaillou|
|Rennes, Ille-et-Vilaine, France, 35000|
|Unité Régionale d'Accueil et de Soins pour Sourds et malentendants - CHRU Nancy|
|Nancy, Meurthe-et-Moselle, France, 54000|
|Groupement des Hôpitaux de l'Institut Catholique de Lille|
|Lille, Nord Pas De Calais, France, 59962|
|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, Hôpital 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|