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RecruitingNCT05875103FluLExUpdated May 25, 2025

The Links Between Executive and Linguistic Processes and Their Lesional Determinants From a Verbal Fluency Task

An interventional study of linguistic processes in Cognitive Neurodegenerative, Stroke and Verbal Fluency Disorders, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
302
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Cognitive Neurodegenerative
  • Stroke
  • Verbal Fluency Disorders

Keywords

  • stroke
  • cognitive neurodegenerative
  • Verbal Fluency Disorders
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 302 is above the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

  • 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:
  • Mild severity impairment (> 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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 \<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 \<30)
  • Hepatic failure (spontaneous > 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

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

Study arms

  • Experimental
    Cognitive cortical neurodegenerative diseases and stroke PATIENTS

    Diagnostic Test: linguistic processes

Interventions

  • Diagnostic testlinguistic processes

    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)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 hour

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05875103
Responsible party
Sponsor
First posted
May 25, 2023
Start date
May 16, 2023
Primary completion
Nov 2029 (estimated)
Completion
Nov 2029 (estimated)
Last update
May 25, 2025

Study contacts

Martine ROUSSEL, PhD
Contact
roussel.martine@chu-amiens.fr
0322668240

Oversight

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

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