Neuropsychological TestsRL-RI-LSFNCT06902753
Adaptation and Normalization of a Verbal Episodic Memory Test in French Sign Language
A study testing Questionnaire and Physical Exam in people with Neuropsychological Tests and Memory, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuropsychological Tests, Memory, Alzheimer Disease
- What is being tested?
- Questionnaire and Physical Exam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2025to Aug 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Person aged ≥ 18 yo
- with severe or profound deafness (hearing loss ≥ 70 decibels), early diagnosed (before 6 years old)
- 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:
Show all 12Show fewer
- 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 not corrected
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
Phase 1: 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.
Phase 2: 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.
- Conditions
- Neuropsychological Tests, Memory, Alzheimer Disease, Deafness, Sign Language, Cognitive Impairment
- Being tested
- Questionnaire and Physical Exam
- Medical subject headings
- Alzheimer Disease, Deafness, Sign Language, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
Phase 1: Single-visit with assessment of cognitive performance (MMS-LS) and fluency tasks (verbal flexibility)
Questionnaire and Physical ExamOther
Phase 2:
- Inclusion visit (M0) with assessment of cognitive performance (MMS-LS), administration of the RL-RI-LSF test, Rey-Osterrieth complex figure and WAIS-IV subtests (matrix reasoning, symbol search, coding).
- Follow-up visit (M9) with assessment of cognitive performance (MMS-LS), administration of the RL-RI-LSF test, Rey-Osterrieth complex figure and WAIS-IV subtests (matrix reasoning, symbol search, coding).
| Study group | Role | What they receive |
|---|---|---|
| Healthy Deaf Signing Group | Experimental | Not described Receives: Other: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
RL-RI-LSF scores for a deaf population without cognitive impairment
The primary objective is to establishe standardized data for the RL-RI-LSF test (adaptation in FSL 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: immediate recall, free recalls, total recalls, recognition scores
Measured: At inclusion of the Phase 2
Secondary outcomes (4)
Association between RL-RI-LSF scores and MMS-LS score
We will provide correlation coefficient between the MMS-LS and each score of the RL-RI-LSF test
Measured: At inclusion for Phase 2
Reliability (test/retest) of the RL-RI-LSF after 9 months
We will provide intraclass correlation coefficient for each RL-RI-LSF score, assessed at inclusion and after a 9-months interval.
Measured: At inclusion and after 9 months for Phase 2
Rey-Osterrieth complex figure scores
We plan to expand the standardized data of the Rey-Osterrieth complex figure among deaf subjects without cognitive impairment, as a continuation of the work initiated by a team in Lille Hospital. The following scores are considered: visuo-spatial copying, immediate recall, delayed recall, recognition.
Measured: At inclusion of the Phase 2
WAIS-IV subtests (Matrix reasoning, Symbol Search, Coding)
We plan to establish standardized data for 3 subtests of the WAIS-IV for a deaf population without cognitive impairment. The following subtests will be considered: matrix reasoning, symbol search, coding.
Measured: At inclusion of the Phase 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start5 May 2025
- Primary completionNov 2027 (estimated)
- Study completionAug 2028 (estimated)
Why it stopped: Inclusions suspended during the period between phase 1 (adaptation of the test in French sign Language) and phase 2 (inclusion for the standardization of the test).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropsychological TestsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is composed of 2 phases. Phase 1 is a single-center study, conducted to develop an adaptation in French Sign Language (FSL) of the RL-RI 16 test. This phase will establish frequency-based lexical lists in FSL using categorical verbal fluency tasts on healthy, signing deaf participants. Phase 2 is a multicentre study, conducted to provide standardized data of the RL-RI6LSf test (=RL-RI 16 adapted in FSL based on the lexical lists obtained in phase 1). The two phases will be separated by a period of approximatively 10 to 14 months, to select the items that will constitute the RL-RI-LSF test and to avoid any potential learning effect in participants who take part in both phases.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Alexandre BERARD, Speech-Language Pathologist, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902753
- Sponsor's protocol ID
- RL-RI-LSF
- Other IDs
- 2024-A02627-40
- Acronym
- RL-RI-LSF
- Status last verified
- Sep 2026
- First submitted
- 30 Dec 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Normalization of a Verbal Episodic Memory Test (16-item Free and Cued Recall / RL-RI 16) in French Sign Language
- ClinicalTrials.gov ID
- NCT06902753
- Acronym / sponsor ID
- RL-RI-LSF / RL-RI-LSF
- Conditions
- Neuropsychological Tests, Memory, Alzheimer Disease, Deafness, Sign Language, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Inclusions suspended during the period between phase 1 (adaptation of the test in French sign Language) and phase 2 (inclusion for the standardization of the test).
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 30 Mar 2025 (actual)
- 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.
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.
Detailed description
Phase 1: 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.
Phase 2: 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is composed of 2 phases. Phase 1 is a single-center study, conducted to develop an adaptation in French Sign Language (FSL) of the RL-RI 16 test. This phase will establish frequency-based lexical lists in FSL using categorical verbal fluency tasts on healthy, signing deaf participants. Phase 2 is a multicentre study, conducted to provide standardized data of the RL-RI6LSf test (=RL-RI 16 adapted in FSL based on the lexical lists obtained in phase 1). The two phases will be separated by a period of approximatively 10 to 14 months, to select the items that will constitute the RL-RI-LSF test and to avoid any potential learning effect in participants who take part in both phases.
| Arm | Type | Receives |
|---|---|---|
| Healthy Deaf Signing Group | Experimental | Other: Questionnaire and Physical Exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Person aged ≥ 18 yo
- with severe or profound deafness (hearing loss ≥ 70 decibels), early diagnosed (before 6 years old)
- 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
Key exclusion criteria (1 listed)
- 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)
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 |
|---|---|---|
| Questionnaire and Physical ExamPhase 1: Single-visit with assessment of cognitive performance (MMS-LS) and fluency tasks (verbal flexibility) | Other | Healthy Deaf Signing Group |
| Questionnaire and Physical ExamPhase 2: * Inclusion visit (M0) with assessment of cognitive performance (MMS-LS), administration of the RL-RI-LSF test, Rey-Osterrieth complex figure and WAIS-IV subtests (matrix reasoning, symbol search, coding). * Follow-up visit (M9) with assessment of cognitive performance (MMS-LS), administration of the RL-RI-LSF test, Rey-Osterrieth complex figure and WAIS-IV subtests (matrix reasoning, symbol search, coding). | Other | Healthy Deaf Signing Group |
Primary outcome
RL-RI-LSF scores for a deaf population without cognitive impairment
Time frame: At inclusion of the Phase 2
The primary objective is to establishe standardized data for the RL-RI-LSF test (adaptation in FSL 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: immediate recall, free recalls, total recalls, recognition scores
4 secondary outcomes
Association between RL-RI-LSF scores and MMS-LS score
Time frame: At inclusion for Phase 2
Reliability (test/retest) of the RL-RI-LSF after 9 months
Time frame: At inclusion and after 9 months for Phase 2
Rey-Osterrieth complex figure scores
Time frame: At inclusion of the Phase 2
WAIS-IV subtests (Matrix reasoning, Symbol Search, Coding)
Time frame: At inclusion of the Phase 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Pierre-Alexandre BERARD, Speech-Language Pathologist principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire and Physical Exam in people with Neuropsychological Tests and Memory, run by Poitiers University Hospital at 1 site 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 12 inclusion and 1 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: paused, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
RL-RI-LSF scores for a deaf population without cognitive impairment (time frame: At inclusion of the Phase 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.