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Adaptation and Normalization of a Verbal Episodic Memory Test in French Sign Language

Adaptation and Normalization of a Verbal Episodic Memory Test (16-item Free and Cued Recall / RL-RI 16) in French Sign Language

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06902753
Acronym
RL-RI-LSF
Enrollment
120
Registered
2025-03-30
Start date
2025-04-30
Completion date
2027-04-30
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Cognitive Impairment, Deafness, Memory, Neuropsychological Tests, Sign Language

Brief summary

To date, neuropsychological assessment of deaf signing persons is complicated by a lack of resources, especially the absence of tools available in French Sign Language (LSF). This is due to perceptual and cultural differences, and in particular the linguistic differences between French and LSF. This lack of resources significantly hinders access to care for deaf patients, as neuropsychological assessment is often a key clinical criterion in the diagnosis of certain neurological pathologies (Alzheimer's disease in particular) and enables coherent care plans to be drawn up, for example in the aftermath of strokes or traumatic brain injuries. In particular, episodic memory (which refers to the ability to memorise information anchored in a specific context) is a cognitive domain that is sensitive to pathologies such as Alzheimer's disease, but it is not currently possible to assess it with deaf signing patients. The aim of this study is to create a memory assessment test adapted to a deaf population that expresses in LSF and to normalize this test on this same population. The aim is to provide a diagnosis assessment tool, which currently does not exist in France, to improve access to care for deaf people. This project could then be extended to the creation of tests for other cognitive domains (executive functions, attention, social cognition, etc.) and to prospects for cognitive remediation. The 16-item Free and Cued Recall test (RL-RI 16) is the best choice because it is easy to use and accurate enough to assess each stage of episodic memory. These qualities make it a decisive tool in certain differential diagnosis. In order to select the most relevant signs, lexical lists by frequency in LSF will be drawn up during a preliminary phase, during which the participants will have to give, in one minute, the maximum number of signs belonging to different categories (animals, vegetables, clothes...). These lists will be used to select the most relevant signs according to their frequency (neither too common nor too rare), based on the same principle as RL-RI 16. It will then be standardised on deaf adults, for whom LSF is the main language, with no cognitive impairment, across France, via the various Deaf Care Units, with the help of French / LSF interpreters. Working with different centers in France will make it possible to recruit a larger and more representative number of participants, and to be more sensitive to any regional effects.

Interventions

OTHERQuestionnaire and Physical Exam

Neuropsychological assessment: * Phase 1: MMS-LS (overall cognitive efficiency) + fluency tasks (verbal flexibility) * Phase 2: MMS-LS (if the participant did not take part in phase 1), RL-RI LSF (verbal memory), Rey Complex Figure (visuospatial abilities and visual memory), Progressive Matrices, Symbols and Code (executive functions)

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Person aged ≥ 18 yo * with severe or profound deafness (hearing loss ≥ 70 decibels) * whose main language is French Sign Language * able to consent in writing after a clear explanation of the procedure * affiliated to the French Healthcare system (Sécurité Sociale) through self or another person Non-inclusion criteria: * person with a medical history in neurology (stroke, traumatic brain injury, dementia) or psychiatry bipolar syndrom or schizophrenia that would not be medicated, severe depression) * persons with medical developmental backgroung (e.g genetic syndrome) * person with cancer history needing chemotherapy * person with a diagnosed and untreated sleeping trouble * person drinking \> 10 glasses of alcohol per week or using drugs on a daily basis * person with visual issues * person under 18yo or unable to take decisions for self

Exclusion criteria

A score ≤ 20/28 or 17/28 at the MMS-LS test, depending on the schooling of the participant (20/28 for participants with a degree, 17/28 for participants without a degree)

Design outcomes

Primary

MeasureTime frameDescription
Normed data for the RL-RI-LSF test for a deaf population without cognitive impairmentPhase 2: 9 monthsThe main goal of this study is to propose normed data for the RL-RI-LSF test (adaptation in LSF of the RL-RI 16 test) for a deaf population without cognitive impairment. The RL-RI-LSF scores correspond to the number of signs correctly recalled by the patient during each recall: * free recalls * cued recalls * recognition scores We will model each RL-RI-LSF score as a function of the participant's gender, age and socio-cultural level. We will present an expected mean score for each age, gender and socio-cultural level class.

Secondary

MeasureTime frameDescription
Correlation RL-RI LSF / MMS-LSPhase 2: 9 monthsThe secondary goal is to assess the correlation of the RL-RI-LSF with the MMS-LS score
Reproductibility over timePhase 2: 9 monthsThe secondary goal is to assess the reproducibility over time (test/retest) of the RL-RI-LSF at 9-month intervals. The reproducibility of the RL-RI-LSF will be assessed by comparing the scores obtained at two different measurement times (RL-RI-LSF tests separated by 9 months) using the intra-class correlation coefficient.
Normative data for the Rey Complex Figure TestPhase 2: 9 monthsThe secondary goal is to propose normalised data for the Rey Complex Figure Test (visuo-spatial copying and memory test) in a French deaf-signing population without cognitive impairment. Each score (copy and memory, /36) will be considered and modeled, if need be, as a function of the participant's gender, age and socio-cultural level. We will present an expected mean score for each age, gender and socio-cultural level class.
Normative data for 3 subtests of the WAIS-IVPhase 2: 9 monthsA secondary outcome is to propose normative data for 3 subtests of the WAIS-IV (Matrices, Symbols, Code) in a deaf-signing population without cognitive impairment. Each raw score will be considered for each test, and modeled, if need be, as a function of the participant's gender, age and socio-cultural level. We will present an expected mean score for each age, gender and socio-cultural level class.

Contacts

Primary ContactPierre-Alexandre BERARD
pierre-alexandre.berard@chu-poitiers.fr+33 5 49 44 44 44

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026