Post-stroke Cognitive Impairment and Dementia "GRECogVASC"

Recruiting

Phase N/A Results N/A

Update History

27 Apr '16
The description was updated.
New
- 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).
Old
- 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).
8 Aug '15
The description was updated.
New
- 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).
Old
- 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 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 (French NeuroVascular Society) and GRECO. - 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 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 3 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); (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).
The eligibility criteria were updated.
New
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
Old
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, 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
7 Dec '11
A location was updated in La rochelle.
New
The overall status was updated to "Recruiting" at CH La Rochelle.
A location was updated in Paris.
New
The overall status was updated to "Recruiting" at HIA Val de Grâce.
A location was updated in Saint Etienne.
New
The overall status was updated to "Recruiting" at CHU Saint Etienne.
6 Oct '11
The description was updated.
New
- 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 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 (French NeuroVascular Society) and GRECO. - 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 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 3 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); (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).
Old
- 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 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 (French NeuroVascular Society) and GRECO. - 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 ? risk =0.05 and power= 80%. In addition, the inclusion of 302 patients allows to determine the frequency of impaired patients with a 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 3 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); (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).