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

Primary Purpose

Cognitive Neurodegenerative, Stroke, Verbal Fluency Disorders

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
linguistic processes
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cognitive Neurodegenerative focused on measuring stroke, cognitive neurodegenerative, Verbal Fluency Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive cortical neurodegenerative diseases and stroke PATIENTS

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 16, 2023
Last Updated
June 6, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT05875103
Brief Title
The Links Between Executive and Linguistic Processes and Their Lesional Determinants From a Verbal Fluency Task
Acronym
FluLEx
Official Title
The Links Between Executive and Linguistic Processes and Their Lesional Determinants From a Verbal Fluency Task
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Neurodegenerative, Stroke, Verbal Fluency Disorders
Keywords
stroke, cognitive neurodegenerative, Verbal Fluency Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive cortical neurodegenerative diseases and stroke PATIENTS
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
linguistic processes
Intervention Description
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)
Primary Outcome Measure Information:
Title
Corelation between Linguistic test performance score and verbal fluency score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martine ROUSSEL, PhD
Phone
0322668240
Email
roussel.martine@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine Roussel, PhD
Phone
0322667813
Email
roussel.martine@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Olivier GODEFROY, Pr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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