Cognitive NeurodegenerativeFluLExNCT05875103
The Links Between Executive and Linguistic Processes and Their Lesional Determinants From a Verbal Fluency Task
A study testing linguistic processes in people with Cognitive Neurodegenerative and Stroke, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Verbal fluency test require to produce as much words as possible in one or two minutes. This test is highly sensitive to main brain diseases and are therefore widely used in clinical routine for diagnostic purpose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Neurodegenerative, Stroke, Verbal Fluency Disorders
- What is being tested?
- linguistic processes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2023to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- For Cognitive cortical neurodegenerative diseases PATIENTS
- informed consentPatients between 40 and 85 years old,
- French native language,
- Social Security affiliation,
- Can read, write and count (up to 36) and knows the alphabet
- Assessed in Amiens University Memory Clinic for:
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- Mild severity impairment (MMSE> 19) or major severity impairment related to:
- AD according to Albert criteria and McKhann criteria
- DCL according to McKeith criteria
- FTLD according to Rascovsky criteria
- CBD according to Armstrong's criteria
- PSP according to Höglinger criteria
- For Stroke PATIENTS
- informed consent
- Patients between 40 and 85 years old,
- French native language,
- Social Security affiliation,
- Can read, write and count (up to 36) and knows the alphabet
- Having suffered a stroke, hospitalized in neurology, visualized by imaging
Who cannot join
- Mental retardation or guardianship
- Other current or past brain condition affecting cognition, including:
- Severe head trauma
- Epilepsy prior to stroke still requiring previous treatment
- Parkinson disease, multiple sclerosis
- Brain tumor or brain radiation therapy
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- Current or past schizophrenia or psychosis
- Active or past psychiatric impairments requiring a stay> 2 days in a specialized environment
- Contra indication to MRI
- Comorbidity with life expectancy <1 year
- Comorbidity affecting cognition in particular:
- Alcohol (> 3 glasses / day) or history of alcohol withdrawal syndrome
- Opiate or cocaine addiction or opiate withdrawal syndrome
- Renal failure (dialysis or creatinine clearance <30)
- Hepatic failure (spontaneous INR> 1.5 or PT <60%)
- Respiratory failure requiring oxygen therapy
- Heart failure (orthopnea> 2 pillows)
- Persistent vigilance disorder (NIHSS1a score ≤1)
- Cancer with paraneoplastic syndrome
- Treatment with gold salts, D Penicillamine or other treatment with cognitive effect
- Patient under guardianship or curators or private under public law
- Pregnant and / or lactating woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Martine Roussel, PhD, 0322667813, roussel.martine@chu-amiens.fr
Olivier GODEFROY, Pr
About this study
Verbal fluency test require to produce as much words as possible in one or two minutes. This test is highly sensitive to main brain diseases and are therefore widely used in clinical routine for diagnostic purpose. The verbal fluency task requires several cognitive processes including executive and linguistic processes for which it is difficult to extract the origin of the deficit. For this reason, fluency tests are variably interpreted in terms of executive or language. The implementation of an experimental protocol exploring each of these processes separately and studying the links between the verbal fluency task and each of these processes should allow a better understanding of the origin of the verbal fluency deficit after brain injury and improve the identification of key brain structures.
Indeed, the lesion determinants of this task remain to be clarified despite remarkable advances due to the evolution of imaging techniques (voxel-based lesion-symptom mapping (VLSM); voxel-based morphometry (VBM)).
Read more
Furthermore, while the direct assessment of linguistic process, semantic memory, and processing speed is well defined, the examination of the executive component (i.e., strategic search process) remains unsettled and will be undertaken in this study.
This work will take advantage of data from previous multicenter work, validated methodologies for both analysis and interpretation of cognitive performance as well as anatomic-clinical correlations at the voxel level and will be performed in cognitive neurodegenerative and cerebrovascular disease.
- Being tested
- linguistic processes
- Keywords
- stroke, cognitive neurodegenerative, Verbal Fluency Disorders
- Medical subject headings
- Stroke, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linguistic processesDiagnostic test
Linguistic processes are assessed by performance score on the following tests:
- naming tests : BNT 34 (Colombo \& Assal, 1992) and semantic naming adapted from the BECS-GRECO (Merck et al., 2011)
- vocabulary test (Mill Hill - Deltour, 1993),
- repetition tests (Gremots - Bézy et al., 2016),
- articulatory speed (Majerus, 2014 ; Roussel et al., 2012)
- semantic matching task adapted from the PPT (Howard \& Patterson, 1992) and from the BECS-GRECO (Merck et al., 2011),
- semantic categorization and attributes adapted from the BECS-GRECO (Merck et al., 2011),
- phonologic and semantic research tasks adapted from the color TMT (D'helia et al., 1996)
| Study group | Role | What they receive |
|---|---|---|
| Cognitive cortical neurodegenerative diseases and stroke PATIENTS | Experimental | Not described Receives: Diagnostic Test: linguistic processes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corelation between Linguistic test performance score and verbal fluency score
Linguistic processes are assessed by performance score on the following tests:
- BNT 34 and semantic naming adapted from the BECS-GRECO
- vocabulary test
- repetition tests
- articulatory speed
- semantic matching task adapted from the PPT and from the BECS-GRECO
- semantic categorization and attributes adapted from the BECS-GRECO
- phonologic and semantic research tasks adapted from the color TMT
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start16 May 2023
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive NeurodegenerativeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875103
- Sponsor's protocol ID
- PI2022_843_0150
- Acronym
- FluLEx
- Status last verified
- May 2025
- First submitted
- 16 May 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Links Between Executive and Linguistic Processes and Their Lesional Determinants From a Verbal Fluency Task
- ClinicalTrials.gov ID
- NCT05875103
- Acronym / sponsor ID
- FluLEx / PI2022_843_0150
- Keywords
- stroke, cognitive neurodegenerative, Verbal Fluency Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 25 May 2023 (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.
Verbal fluency test require to produce as much words as possible in one or two minutes. This test is highly sensitive to main brain diseases and are therefore widely used in clinical routine for diagnostic purpose. The verbal fluency task requires several cognitive processes including executive and linguistic processes for which it is difficult to extract the origin of the deficit. For this reason, fluency tests are variably interpreted in terms of executive or language. The implementation of an experimental protocol exploring each of these processes separately and studying the links between the verbal fluency task and each of these processes should allow a better understanding of the origin of the verbal fluency deficit after brain injury and improve the identification of key brain structures.
Indeed, the lesion determinants of this task remain to be clarified despite remarkable advances due to the evolution of imaging techniques (voxel-based lesion-symptom mapping (VLSM); voxel-based morphometry (VBM)).
Furthermore, while the direct assessment of linguistic process, semantic memory, and processing speed is well defined, the examination of the executive component (i.e., strategic search process) remains unsettled and will be undertaken in this study.
This work will take advantage of data from previous multicenter work, validated methodologies for both analysis and interpretation of cognitive performance as well as anatomic-clinical correlations at the voxel level and will be performed in cognitive neurodegenerative and cerebrovascular disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive cortical neurodegenerative diseases and stroke PATIENTS | Experimental | Diagnostic Test: linguistic processes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- For Cognitive cortical neurodegenerative diseases PATIENTS
- informed consentPatients between 40 and 85 years old,
- French native language,
- Social Security affiliation,
- Can read, write and count (up to 36) and knows the alphabet
Key exclusion criteria (22 listed)
- Mental retardation or guardianship
- Other current or past brain condition affecting cognition, including:
- Severe head trauma
- Epilepsy prior to stroke still requiring previous treatment
- Parkinson disease, multiple sclerosis
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 |
|---|---|---|
| linguistic processesLinguistic processes are assessed by performance score on the following tests: * naming tests : BNT 34 (Colombo \& Assal, 1992) and semantic naming adapted from the BECS-GRECO (Merck et al., 2011) * vocabulary test (Mill Hill - Deltour, 1993), * repetition tests (Gremots - Bézy et al., 2016), * articulatory speed (Majerus, 2014 ; Roussel et al., 2012) * semantic matching task adapted from the PPT (Howard \& Patterson, 1992) and from the BECS-GRECO (Merck et al., 2011), * semantic categorization and attributes adapted from the BECS-GRECO (Merck et al., 2011), * phonologic and semantic research tasks adapted from the color TMT (D'helia et al., 1996) | Diagnostic test | Cognitive cortical neurodegenerative diseases and stroke PATIENTS |
Primary outcome
Corelation between Linguistic test performance score and verbal fluency score
Time frame: 1 hour
Linguistic processes are assessed by performance score on the following tests: * BNT 34 and semantic naming adapted from the BECS-GRECO * vocabulary test * repetition tests * articulatory speed * semantic matching task adapted from the PPT and from the BECS-GRECO * semantic categorization and attributes adapted from the BECS-GRECO * phonologic and semantic research tasks adapted from the color TMT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing linguistic processes in people with Cognitive Neurodegenerative and Stroke, run by Centre Hospitalier Universitaire, Amiens 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 19 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 25 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martine ROUSSEL, PhD (0322668240, roussel.martine@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corelation between Linguistic test performance score and verbal fluency score (time frame: 1 hour). 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 25 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.