## Protocol Section
### Identification Module
**NCT ID:** NCT02005679

**Acronym:** MMS-LS

**Brief Title:** Mini-Mental State (MMS-LS) and Sign Language

**Official Title:** Transposition of the Mini-Mental State in Sign Language

#### Organization Study ID Info
**ID:** RC-P0008
#### Organization
**Class:** OTHER
**Full Name:** Lille Catholic University
### Status Module
#### Completion Date
**Date:** 2017-12-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-02-15

**Type:** ACTUAL

**Last Update Submit Date:** 2019-02-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-12-07

**Type:** ACTUAL

#### Start Date
**Date:** 2011-06-17

**Type:** ACTUAL

**Status Verified Date:** 2019-02

#### Study First Post Date
**Date:** 2013-12-09
**Type:** ESTIMATED
**Study First Submit Date:** 2013-11-22
**Study First Submit QC Date:** 2013-12-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Lille Catholic University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Prelingual Deafness

- Retention Disorders, Cognitive

**Keywords:**

- Prelingual Deafness

- Retention Disorders, Cognitive

- Sign language

- Mini-Mental State

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 195

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: application of the mini-mental state test

**Label:** deaf persons with potential dementia

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- deaf persons with potential dementia

**Name:** application of the mini-mental state test

**Type:** BEHAVIORAL

### Outcomes Module

#### 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

**Time Frame:** At baseline, 1 year and 2 years follow-up visits

#### Secondary Outcomes

**Description:** Explanatory Factors are: age, education level, characteristics of the sign language(fluency level, learning age, usage frequency, usage by other family members)

**Measure:** Description of MMS-LS test results

**Time Frame:** Baseline

**Description:** Sensitivity, specificity, positive and negative predictive values.

**Measure:** Diagnostic performance and predictive values of MMS-LS test for acquired dementia.

**Time Frame:** Baseline, 1 year and 2 years follow-up visits

**Description:** We also check that patients having a suspicious CDR (0.5) have a superior MMS-LS score compared to patients having a CDR ≥ 1.

**Measure:** Correlation between MMS-LS score and CDR level

**Time Frame:** Baseline, 1 year and 2 years follow-up visits

**Description:** Sensitivity, specificity, positive and negative predictive values

**Measure:** Diagnostic performance and predictive values of MMS-LS test for suspected dementia.

**Time Frame:** Baseline, 1 year and 2 years follow-up visits

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Marseille

**Country:** France

**Facility:** Hôpital de la Conception, Pôle psychiatrie Centre

**State:** Bouches-du-Rhône

**Zip:** 13885

**Location 2:**

**City:** Rennes

**Country:** France

**Facility:** CHU de Rennes, Hôpital de Pontchaillou

**State:** Ille-et-Vilaine

**Zip:** 35000

**Location 3:**

**City:** Nancy

**Country:** France

**Facility:** Unité Régionale d'Accueil et de Soins pour Sourds et malentendants - CHRU Nancy

**State:** Meurthe-et-Moselle

**Zip:** 54000

**Location 4:**

**City:** Lille

**Country:** France

**Facility:** Groupement des Hôpitaux de l'Institut Catholique de Lille

**State:** Nord Pas De Calais

**Zip:** 59962

#### Overall Officials

**Official 1:**

**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

**Official 2:**

**Affiliation:** Groupement des Hôpitaux de l'Institut Catholique de Lille, Medical Research Department

**Name:** Amélie Lansiaux, MD

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** CHU de Rennes, Hôpital de Pontchaillou

**Name:** Isabelle Ridoux, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** Hôpital de la Conception, Pôle psychiatrie, Marseille

**Name:** Corine Gilda Scemama-Ammar, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 5:**

**Affiliation:** Groupement des Hôpitaux de l'Institut Catholique de Lille

**Name:** Charlotte Crinquette, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 6:**

**Affiliation:** CHRU de Nancy, Unité Régionale d'Accueil et de Soins pour Sourds et malentendants

**Name:** Isabelle Bouillevaux, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006311

- Term: Hearing Disorders

- ID: D000004427

- Term: Ear Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

- ID: D000012678

- Term: Sensation Disorders

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000019954

- Term: Neurobehavioral Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M24420

- Name: Hearing Loss

- Relevance: HIGH

- As Found: Deafness

- ID: M6840

- Name: Deafness

- Relevance: HIGH

- As Found: Prelingual Deafness

- ID: M11552

- Name: Memory Disorders

- Relevance: HIGH

- As Found: Retention Disorders, Cognitive

- ID: M9400

- Name: Hearing Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7601

- Name: Ear Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15490

- Name: Sensation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003638

- Term: Deafness

- ID: D000034381

- Term: Hearing Loss

- ID: D000008569

- Term: Memory Disorders

### Misc Info Module

- Version Holder: 2024-05-24
