Prelingual DeafnessMMS-LSNCT02005679
Mini-Mental State (MMS-LS) and Sign Language
A study testing application of the mini-mental state test in people with Prelingual Deafness and Retention Disorders, Cognitive, run by Lille Catholic University at 4 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prelingual Deafness, Retention Disorders, Cognitive
- What is being tested?
- application of the mini-mental state test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 4 sitesFrance
- Study dates
- 17 Jun 2011to 7 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults> 18 years
- Pre-lingual deafness
- Use of French sign language
Who cannot join
- Refusal to sign the consent
- Severe visual impairment with lower acuity (less than 0.5)
- Severe motor difficulties impeding the practice of sign language
Trial locations and contacts
4 sites in 1 country.
France4 sites
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille, Hauts-de-France, 59962
Hôpital de la Conception, Pôle psychiatrie Centre
Marseille, Bouches-du-Rhône, 13885
Unité Régionale d'Accueil et de Soins pour Sourds et malentendants - CHRU Nancy
Nancy, Meurthe-et-Moselle, 54000
CHU de Rennes, Hôpital de Pontchaillou
Rennes, Ille-et-Vilaine, 35000
About this study
Official title: 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.
Read the 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.
- Being tested
- application of the mini-mental state test
- Keywords
- Prelingual Deafness, Retention Disorders, Cognitive, Sign language, Mini-Mental State
- Medical subject headings
- Deafness, Memory Disorders, Sign Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of the mini-mental state testBehavioural
| Study group | Role | What they receive |
|---|---|---|
| deaf persons with potential dementia | Experimental | Not described Receives: Behavioral: application of the mini-mental state test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline, 1 year and 2 years follow-up visits
Secondary outcomes (4)
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)
Measured: Baseline
Diagnostic performance and predictive values of MMS-LS test for acquired dementia.
Sensitivity, specificity, positive and negative predictive values.
Measured: 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.
Measured: 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
Measured: Baseline, 1 year and 2 years follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study start17 Jun 2011
- Primary completion7 Dec 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prelingual DeafnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoît Drion, MD, Study director, 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 SantéAmélie Lansiaux, MD, Study chair, Groupement des Hôpitaux de l'Institut Catholique de Lille, Medical Research DepartmentIsabelle Ridoux, MD, Principal investigator, CHU de Rennes, Hôpital de PontchaillouCorine Gilda Scemama-Ammar, MD, Principal investigator, Hôpital de la Conception, Pôle psychiatrie, MarseilleCharlotte Crinquette, MD, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de LilleIsabelle Bouillevaux, MD, Principal investigator, CHRU de Nancy, Unité Régionale d'Accueil et de Soins pour Sourds et malentendants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005679
- Sponsor's protocol ID
- RC-P0008
- Acronym
- MMS-LS
- Status last verified
- Feb 2019
- First submitted
- 22 Nov 2013
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Fleurion D, Vignal F, Drion B. Normative Data For Nonverbal Memory Tests In A Sample Of Deaf Adults that use French Sign Language. J Clin Exp Neuropsychol. 2025 Jul;47(5):495-507. doi: 10.1080/13803395.2025.2530564. Epub 2025 Jul 10.
PubMed 40640105
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transposition of the Mini-Mental State in Sign Language
- ClinicalTrials.gov ID
- NCT02005679
- Acronym / sponsor ID
- MMS-LS / RC-P0008
- Keywords
- Prelingual Deafness, Retention Disorders, Cognitive, Sign language, Mini-Mental State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 17 Jun 2011 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| deaf persons with potential dementia | Experimental | Behavioral: application of the mini-mental state test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults> 18 years
- Pre-lingual deafness
- Use of French sign language
Key exclusion criteria (3 listed)
- Refusal to sign the consent
- Severe visual impairment with lower acuity (less than 0.5)
- Severe motor difficulties impeding the practice of sign language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application of the mini-mental state test | Behavioural | deaf persons with potential dementia |
Primary outcome
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
4 secondary outcomes
Description of MMS-LS test results
Time frame: Baseline
Diagnostic performance and predictive values of MMS-LS test for acquired dementia.
Time frame: Baseline, 1 year and 2 years follow-up visits
Correlation between MMS-LS score and CDR level
Time frame: Baseline, 1 year and 2 years follow-up visits
Diagnostic performance and predictive values of MMS-LS test for suspected dementia.
Time frame: Baseline, 1 year and 2 years follow-up visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 40640105Fleurion D, Vignal F, Drion B. Normative Data For Nonverbal Memory Tests In A Sample Of Deaf Adults that use French Sign Language. J Clin Exp Neuropsychol. 2025 Jul;47(5):495-507. doi: 10.1080/13803395.2025.2530564. Epub 2025 Jul 10.
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Severe to Profound Prelingual Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoît Drion, MD study director
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
Amélie Lansiaux, MD study chair
Groupement des Hôpitaux de l'Institut Catholique de Lille, Medical Research Department
Isabelle Ridoux, MD principal investigator
CHU de Rennes, Hôpital de Pontchaillou
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of the mini-mental state test in people with Prelingual Deafness and Retention Disorders, Cognitive, run by Lille Catholic University at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02005679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.