Post-stroke Cognitive Impairment and Dementia (GRECogVASC)

September 16, 2025 updated by: Centre Hospitalier Universitaire, Amiens

Post-stroke Cognitive Impairment and Dementia: Frequency and Anatomical Correlates With the French Version of the National Institute of Neurological Disorders and Stroke (NINDS)-Canadian Stroke Network Battery

Projections from epidemiological studies suggest that, among the Western adult population, one in three will present a cerebrovascular accident (stroke), severe cognitive disorders, or both. To better diagnose the Vascular Cognitive Impairment, new standards were developed by a North America working group which are under validation. It is essential to adapt these standard for French-speaking population, and especially to define cutoff scores of the cognitive battery to determine cognitive deficit.

The investigators propose a study coordinated by the University-Hospital of Amiens for french speaking centers. This study will investigate this battery with 906 controls to define the standards and 302 stroke affected patients to define the frequency and cognitive mechanisms. This step is essential for people to benefit from these new standards.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Context In western countries, one in three subjects will experience a stroke, dementia or both. Recent studies have shown the major role of vascular risk factors and stroke in cognitive disorders and dementia. Poststroke cognitive and behavioral disorders are characterized by the prominence of action slowing, executive function disorders and apathy. They are due to vascular lesions or to associated pathology, mainly Alzheimer's disease. In order to determine diagnosis criteria of Vascular Cognitive Impairment, it is necessary to develop a standardized assessment of post-stroke cognitive and behavioral disorders (Hachinski et al Stroke 2006; 37; 2220-2241). For this purpose, the NINDS (National Institute of Neurological Disorders and Stroke

    ) and the Canadian Stroke Network have jointly developed a specific standardized battery which is currently under validation. Its use in France requires first a normalization of some tests in French speaking healthy controls. This study is supported by the SFNV (Société Française NeuroVasculaire) and GRECO (Groupe de Réflexion sur les Evaluations Cognitives).

  • Primary Objectives of the project: to determine the frequency of cognitive and behavioral disorders 6 months post-stroke assessed with this new NINDS-Canadian Stroke Network battery Primary endpoints: disorders on cognitive tests and on behavioral and depression questionnaires (defined by performance outside normal ranges determined in healthy controls);
  • Population Patients consecutive French-speaking patients with an informant assessed 6 months post-stroke and free from mental retardation, psychosis, illiteracy, previously diagnosed dementia, comorbidity known to impair cognitive abilities, MRI contraindication or refusal to participate.

Controls from the general population not presenting any condition known to impair cognitive abilities stratified according to age and schooling levels

  • Design Prospective multicenter study comparing performance of patients and controls Sample size: the frequencies of cognitive and behavioral disorders are considered as significantly different if the null hypothesis (lack of difference between groups at the 0.05 quantile) is rejected. Considering that each patient is matched with 3 controls, it will be necessary to evaluate 302 patients with the battery 6 months poststroke and 906 controls to detect a difference between groups of at least 5% with α risk =0.05 and power= 80%. In addition, the inclusion of 302 patients allows to determine the frequency of impaired patients with a confidence interval CI95% ≤12%.
  • Feasibility: based on a previous similar study, 50 stroke patients (range 40-60) and 150 controls (range: 100-200) will be included per year in the University Hospital of Amiens. Thus 10 centers with similar inclusion rates will be able to include 302 patients and 906 controls within 6 years.
  • Secondary objectives: (1) to determine the frequency of poststroke dementia; (2) to determine the frequency of cognitive disorders on screening tests; (3) to examine correlations between cerebral MRI and cognitive impairment; (4) to determine correlations between cognitive disorders and activities of daily living.

Secondary endpoints: (1) dementia (DSMIV and NINDS-AIREN criteria ;National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences ); (2) screening tests (MiniMental Status Examination, Montreal Cognitive Assessment);(3) MRI abnormalities (cerebral atrophy, white matter abnormalities, stroke type, stroke volume and location) using 3D T1-weighted (axial bicommissural plane), T2-weighted (coronal plan), FLAIR, gradient-echo, diffusion-weighted (with calculation of the apparent diffusion coefficient) performed at 6 months post-stroke at the same time than the cognitive assessment; (4) disability in activities of daily living (Rankin scale, Barthel index, Instrumental Activities of Daily Living).

Study Type

Interventional

Enrollment (Actual)

1635

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 Locations

  • France
      • Brest, France, 29200
        • CHU Brest
      • Dijon, France, 21000
        • Chu Dijon
      • La Rochelle, France, 17000
        • CH La Rochelle
      • Paris, France, 75000
        • HIA Val de Grâce
      • Saint-Etienne, France, 42000
        • CHU Saint Etienne
    • Pas-de-calais
      • Lille, Pas-de-calais, France, 59000
        • CHRU Lille
    • Picardie
      • Amiens, Picardie, France, 80000
        • CHU Amiens

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • Patients:management at the acute phase (duration < 30 days) of stroke visualized by imaging, age between 40 and 80 years, French-speaking, reliable informant, agreeing to participate in the study.
  • Controls: derived from the general population and consenting to participate in the study.

Exclusion criteria:

  • Patients: mental retardation, illiteracy, known dementia, schizophrenia or psychosis or history of psychiatric illness requiring a stay for > 2 days in a psychiatry unit, comorbidities affecting cognition, persistent disturbance of consciousness, contraindication to MRI.
  • Controls: illiteracy, deficit on MMSE (Mini-Mental State Examination), visual, auditory or motor deficit, history of brain disease or psychiatric illness (schizophrenia or other psychosis) or ongoing psychiatric illness (depression or other) currently requiring treatment or requiring a stay > 2 days in psychiatry unit or anxiety requiring more than one medication at the present time, alcoholism, opiate or illicit drug use < 3 months, ongoing antidepressant or antiepileptic treatment, recent anxiolytic or hypnotic treatment, general anaesthesia < 3 months, history of heart surgery with cardiopulmonary bypass

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral
Behavioral: French adaptation of NINDS-Canadian Stroke Network battery
Behavioral: French adaptation of NINDS-Canadian Stroke Network battery
  • clinical: post-stroke neurological follow-up assessment
  • neuropsychological: comprising the NINDS-Canadian Stroke Network neuropsychological battery
  • MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine the frequency of cognitive and behavioral disorders 6 months post-stroke assessed with this new NINDS-Canadian Stroke Network battery
Time Frame: 6 month
deficit (as compared with control performance) on battery of tests assessing instrumental (oral naming, copy of complex figure)and executive fucntions (verbal fluency, Trail Making, reaction time tests), episodic memory for verbal and visual materials and behavioral changes
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine the proportion of patients with dementia
Time Frame: 6 month
composite index including memory and cognitive disorders and decline in every day life activities
6 month
determine the value of cognitive screening tests
Time Frame: 6 month
performance on MiniMental State Examination and Montreal Cognitive Assessment
6 month

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Study Chair: Olivier Godefroy, PhD-MD, CHU Amiens
  • Principal Investigator: Hilde Henon, MD, CHRU Lille
  • Principal Investigator: Hervé Taillia, PhD-MD, HIA Val de Grâce
  • Principal Investigator: Serge Timsit, PhD-MD, CHU Brest
  • Principal Investigator: Claudine Nedelec, MD, CH La Rochelle
  • Principal Investigator: Maurice Giroud, PhD-MD, Chu Dijon
  • Principal Investigator: catherine thomas, MD, Chu Saint-Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2010

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 22, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimated)

April 20, 2011

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOL10-PR-GODEFROY
  • 2010-A00657-32 (Other Identifier: CHU)

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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