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

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 Overview

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Amiens, France, 80054
        • Recruiting
        • CHU Amiens
        • Contact:
        • Sub-Investigator:
          • Olivier GODEFROY, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 (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

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive cortical neurodegenerative diseases and stroke PATIENTS

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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