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

This study is currently recruiting participants.
Verified September 2016 by Lille Catholic University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02005679
First Posted: December 9, 2013
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Lille Catholic University
  Purpose

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 Intervention
Prelingual Deafness Retention Disorders, Cognitive Behavioral: application of the mini-mental state test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transposition of the Mini-Mental State in Sign Language

Resource links provided by NLM:


Further study details as provided by Lille Catholic University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Estimated Enrollment: 185
Study Start Date: June 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: deaf persons with potential dementia 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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Magali Demilly, PhD +33 3 20 22 57 00 Demilly.Magalie@ghicl.net
Contact: Gabriela Certad, MD +33 3 20 22 57 35 certad.gabriela@ghicl.net

Locations
France
Hôpital de la Conception, Pôle psychiatrie Centre Recruiting
Marseille, Bouches-du-Rhône, France, 13885
Principal Investigator: Corine Gilda Scemama-Ammar, MD         
CHU de Rennes, Hôpital de Pontchaillou Recruiting
Rennes, Ille-et-Vilaine, France, 35000
Principal Investigator: Isabelle Ridoux, MD         
Sub-Investigator: Anne-Sophie Le Leuch, Psychologist         
Unité Régionale d'Accueil et de Soins pour Sourds et malentendants - CHRU Nancy Not yet recruiting
Nancy, Meurthe-et-Moselle, France, 54000
Principal Investigator: Isabelle Bouillevaux, MD         
Groupement des Hôpitaux de l'Institut Catholique de Lille Recruiting
Lille, Nord Pas de Calais, France, 59962
Principal Investigator: Benoît Drion, MD         
Sub-Investigator: Charlotte Crinquette, MD         
Sub-Investigator: Delphine Leuse, Psychologist         
Sub-Investigator: Delphine Fleurion, Psychologist         
Sponsors and Collaborators
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, 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
  More Information

Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02005679     History of Changes
Other Study ID Numbers: RC-P0008
First Submitted: November 22, 2013
First Posted: December 9, 2013
Last Update Posted: September 20, 2016
Last Verified: September 2016

Keywords provided by Lille Catholic University:
Prelingual Deafness
Retention Disorders, Cognitive
Sign language
Mini-Mental State

Additional relevant MeSH terms:
Deafness
Hearing Loss
Memory Disorders
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurobehavioral Manifestations