ClinicalTrials.gg
SuspendedNCT06902753RL-RI-LSFUpdated Oct 27, 2026

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

An interventional study of Questionnaire and Physical Exam and Questionnaire and Physical Exam in Neuropsychological Tests, Memory and Alzheimer Disease, sponsored by Poitiers University Hospital. Suspended at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Other

Why this study was suspended
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).
Updated Oct 27, 2026Now SuspendedStudy documents posted+8 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Neuropsychological Tests
  • Memory
  • Alzheimer Disease
  • Deafness
  • Sign Language
  • Cognitive Impairment
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 120 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Poitiers University Hospital is the lead sponsor of 314 studies on the registry; 62 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 16, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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:

  • 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

Exclusion criteria

Exclusion Criteria (post-inclusion):

- 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)

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Healthy Deaf Signing Group

    Other: Questionnaire and Physical Exam

Interventions

  • OtherQuestionnaire and Physical Exam

    Phase 1: Single-visit with assessment of cognitive performance (MMS-LS) and fluency tasks (verbal flexibility)

  • OtherQuestionnaire and Physical Exam

    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).

06

What researchers measure

Primary outcomes

  1. RL-RI-LSF scores for a deaf population without cognitive impairment

    The primary objective is to establish 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

    Time frame: At inclusion of the Phase 2

Secondary outcomes

  1. Association between RL-RI-LSF scores and MMS-LS score

    Correlation coefficient between the MMS-LS and each score of the RL-RI-LSF test will be provided

    Time frame: At inclusion for Phase 2

  2. Reliability (test/retest) of the RL-RI-LSF after 9 months

    Intraclass correlation coefficient for each RL-RI-LSF score will be provided. RL-RI-LSF score will be assessed at inclusion and after a 9-months interval.

    Time frame: At inclusion and after 9 months for Phase 2

  3. Rey-Osterrieth complex figure scores

    The investigators 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.

    Time frame: At inclusion of the Phase 2

  4. WAIS-IV subtests (Matrix reasoning, Symbol Search, Coding)

    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.

    Time frame: At inclusion of the Phase 2

07

Study locations

1 site
  • Poitiers University Hospital
    Poitiers, 86000, France
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started May 2025 (actual). Primary completion is estimated for Nov 2027, 30 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: start Apr 2025 → May 2025, primary completion Jan 2027 → Nov 2027 and completion Apr 2027 → Aug 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 30, 2024
First posted
Mar 30, 2025
StartActual
May 5, 2025was Apr 2025
Primary completionEst.
Nov 2027was Jan 2027
CompletionEst.
Aug 2028was Apr 2027
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Suspended 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).
changed Oct 16, 2026
Sites
1 site added — first site in France
Show site
  • Poitiers University Hospital · Poitiers, France
Oct 16, 2026
Start date
Apr 2025→May 5, 2025 (actual)
Oct 16, 2026
Primary completion
Jan 2027→Nov 2027
Oct 16, 2026
Study completion
Apr 2027→Aug 2028
Oct 16, 2026
Eligibility
2 inclusion criteria edited, 1 removed
What changed in the criteria
Inclusion criteria
  • Editedwith severe or profound deafness (hearing loss ≥ 70 decibels), early diagnosed (before 6 years old)
  • Editedperson with visual issues not corrected
  • Removedperson under 18yo or unable to take decisions for self
Oct 16, 2026
Interventions
Added Questionnaire and Physical Exam
Oct 16, 2026
Primary outcomes
Revised in 2 updates
What changed on Oct 16, 2026
  • EditedNormed data for the RL-RI-LSF testscores for a deaf population without cognitive impairmentTime frame: Phase 2: 9 months → At inclusion of the Phase 2
What changed on Oct 27, 2026
  • DescriptionRL-RI-LSF scores for a deaf population without cognitive impairment: how it is measured was reworded
across 2 updates, Oct 16, 2026 – Oct 27, 2026
Documents
Secondary outcomes
Revised in 2 updates
What changed on Oct 16, 2026
  • EditedCorrelationAssociation between RL-RI -LSF /scores and MMS-LS scoreTime frame: Phase 2: 9 months → At inclusion for Phase 2
  • AddedReliability (test/retest) of the RL-RI-LSF after 9 monthsTime frame: At inclusion and after 9 months for Phase 2
  • AddedRey-Osterrieth complex figure scoresTime frame: At inclusion of the Phase 2
  • AddedWAIS-IV subtests (Matrix reasoning, Symbol Search, Coding)Time frame: At inclusion of the Phase 2
  • RemovedReproductibility over timeTime frame: Phase 2: 9 months
  • RemovedNormative data for the Rey Complex Figure TestTime frame: Phase 2: 9 months
  • RemovedNormative data for 3 subtests of the WAIS-IVTime frame: Phase 2: 9 months
What changed on Oct 27, 2026
  • DescriptionAssociation between RL-RI-LSF scores and MMS-LS score: how it is measured was reworded
  • DescriptionReliability (test/retest) of the RL-RI-LSF after 9 months: how it is measured was reworded
  • DescriptionRey-Osterrieth complex figure scores: how it is measured was reworded
  • DescriptionWAIS-IV subtests (Matrix reasoning, Symbol Search, Coding): how it is measured was reworded
across 2 updates, Oct 16, 2026 – Oct 27, 2026
Show all 2 updates
  1. Oct 27, 2026
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionRL-RI-LSF scores for a deaf population without cognitive impairment: how it is measured was reworded
    Secondary outcomes 4 description edited
    What changed in the outcomes
    • DescriptionAssociation between RL-RI-LSF scores and MMS-LS score: how it is measured was reworded
    • DescriptionReliability (test/retest) of the RL-RI-LSF after 9 months: how it is measured was reworded
    • DescriptionRey-Osterrieth complex figure scores: how it is measured was reworded
    • DescriptionWAIS-IV subtests (Matrix reasoning, Symbol Search, Coding): how it is measured was reworded
    + 2 other changes: verification date and criteria formatting
  2. Oct 16, 2026
    Not yet recruiting→Suspended
    Why 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).
    1 site added — first site in France
    Show site
    • Poitiers University Hospital · Poitiers, France
    Start date Apr 2025→May 5, 2025 (now actual)
    Primary completion Jan 2027→Nov 2027
    Study completion Apr 2027→Aug 2028
    Eligibility 2 inclusion criteria edited, 1 removed
    What changed in the criteria
    Inclusion criteria
    • Editedwith severe or profound deafness (hearing loss ≥ 70 decibels), early diagnosed (before 6 years old)
    • Editedperson with visual issues not corrected
    • Removedperson under 18yo or unable to take decisions for self
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedNormed data for the RL-RI-LSF testscores for a deaf population without cognitive impairmentTime frame: Phase 2: 9 months → At inclusion of the Phase 2
    Secondary outcomes 1 edited, 3 added, 3 removed
    What changed in the outcomes
    • EditedCorrelationAssociation between RL-RI -LSF /scores and MMS-LS scoreTime frame: Phase 2: 9 months → At inclusion for Phase 2
    • AddedReliability (test/retest) of the RL-RI-LSF after 9 monthsTime frame: At inclusion and after 9 months for Phase 2
    • AddedRey-Osterrieth complex figure scoresTime frame: At inclusion of the Phase 2
    • AddedWAIS-IV subtests (Matrix reasoning, Symbol Search, Coding)Time frame: At inclusion of the Phase 2
    • RemovedReproductibility over timeTime frame: Phase 2: 9 months
    • RemovedNormative data for the Rey Complex Figure TestTime frame: Phase 2: 9 months
    • RemovedNormative data for 3 subtests of the WAIS-IVTime frame: Phase 2: 9 months
    Interventions Added Questionnaire and Physical Exam
    + 8 other changes: index terms, identifiers, verification date, oversight details, description, design details, contact details and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06902753
Responsible party
Sponsor
First posted
Mar 30, 2025
Start date
May 5, 2025
Primary completion
Nov 2027 (estimated)
Completion
Aug 2028 (estimated)
Last update
Oct 27, 2026

Study contacts

Pierre-Alexandre BERARD, Speech-Language Pathologist
principal investigator · Poitiers University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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