- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05875103
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
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Martine ROUSSEL, PhD
- Phone Number: 0322668240
- Email: roussel.martine@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80054
- Recruiting
- CHU Amiens
-
Contact:
- Martine Roussel, PhD
- Phone Number: 0322667813
- Email: roussel.martine@chu-amiens.fr
-
Sub-Investigator:
- Olivier GODEFROY, Pr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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:
|
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:
|
1 hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2022_843_0150
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on linguistic processes
-
University Hospital, AngersCompleted
-
Michigan State UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingAutism Spectrum DisorderUnited States
-
Aysegul KilicliRecruiting
-
Lebanese UniversityCompletedChild Behavior | Academic Skill DisorderLebanon
-
Inonu UniversityCompletedKidney Transplant PatientsTurkey
-
University Hospital, ToulouseCompletedAphasia, AcquiredFrance
-
Intermountain Health Care, Inc.National Institutes of Health (NIH); McKay-Dee Hospital; Utah Valley Hospital; Dixie...RecruitingAcute Respiratory Distress SyndromeUnited States
-
Necmettin Erbakan UniversityRecruitingRetinopathy of Prematurity | NewbornTurkey
-
Munzur UniversityCompletedPain, Postoperative | Nursing CariesTurkey