NCT05875103

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
May 2023Nov 2029

First Submitted

Initial submission to the registry

May 16, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

6.5 years

First QC Date

May 16, 2023

Last Update Submit

May 21, 2025

Conditions

Keywords

strokecognitive neurodegenerativeVerbal Fluency Disorders

Outcome Measures

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

    1 hour

Study Arms (1)

Cognitive cortical neurodegenerative diseases and stroke PATIENTS

EXPERIMENTAL
Diagnostic Test: linguistic processes

Interventions

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)

Cognitive cortical neurodegenerative diseases and stroke PATIENTS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • +4 more criteria

You may not qualify if:

  • 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%)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

StrokeSpeech Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Martine ROUSSEL, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 25, 2023

Study Start

May 16, 2023

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations