Adaptation and Normalization of a Verbal Episodic Memory Test in French Sign Language (RL-RI-LSF)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Impairment; Alzheimer Disease; Deafness; Memory; Neuropsychological Tests; Sign Language
• Intervention / Treatment: Other: Questionnaire and Physical Exam

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre-Alexandre BERARD; Phone Number: poste 47026 +33 5 49 44 44 44; Email: pierre-alexandre.berard@chu-poitiers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Deaf Signing Group	Other: Questionnaire 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normed data for the RL-RI-LSF test for a deaf population without cognitive impairment	The 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.	Phase 2: 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation RL-RI LSF / MMS-LS	The secondary goal is to assess the correlation of the RL-RI-LSF with the MMS-LS score	Phase 2: 9 months
Reproductibility over time	The 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.	Phase 2: 9 months
Normative data for the Rey Complex Figure Test	The 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.	Phase 2: 9 months
Normative data for 3 subtests of the WAIS-IV	A 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.	Phase 2: 9 months

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Principal Investigator: Pierre-Alexandre BERARD, Speech-Language Pathologist, Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Alzheimer Disease; Deafness
• Other Study ID Numbers: 2024-A02627-40

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No