Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies

Study Overview
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Brief Summary
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The role of disorders of socio-emotional processes in cerebral diseases such as Alzheimer's disease, frontal temporal dementia, Parkinson's disease, Huntington's disease, traumatic brain injury, stroke, focal lesions, has been recognized recently. Social cognition refers to a large group of emotional and cognitive abilities regulating inter-individuals relationships and it includes mainly theory of mind, emotional information processing and empathy. However, assessment of socio-emotional processes is still largely based on experimental tests that are not validated for clinical purpose. In addition their long duration of administration is not adapted to clinical examination. Finally these tests have not been standardized and normalized in French-speaking population.

Official Title
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Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies

Conditions
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Alzheimer Disease, Parkinson Disease, Stroke, Frontal Dementia, Huntington Disease, Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: social cognition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form (ICF) Male or female, aged 20 to 80 years inclusive at the time of signing ICF French-speaking reliable informant Controls: derived from the general population and consenting to participate in the study Patients: MMS>18 Patients followed for mild or major neurocognitive disorder related to : Alzheimer's disease Frontotemporal lobar degeneration Lewy bodies disease Parkinson's disease Huntington's disease Progressive supranuclear palsy traumatic brain injury stroke or cerebral anoxia mixed diseases focal cerebral diseases Exclusion Criteria: Illiteracy mental retardation visual or motor deficit preventing reading, drawing or writing (scores on the reading, drawing or sentence writing subtests of the MMSE = 0) hearing impairment interfering with understanding of instructions, history of brain disease, including head injury with loss of consciousness lasting > 15 minutes, stroke, coma or loss of consciousness lasting > 15 minutes, followed for sclerosis or other brain disease, brain radiation therapy, epilepsy currently requiring treatment history of psychiatric illness (schizophrenia or other psychosis) or ongoing psychiatric illness (major depressive disorder or other condition) currently requiring treatment or requiring a stay > 2 days in a psychiatry unit or anxiety requiring more than one medication at the present time alcoholism (mean alcohol consumption > 3 standard drinks/day or history of alcohol withdrawal) use of opiates or other illicit drugs during the previous 3 months or causing withdrawal syndrome ongoing antidepressant or antiepileptic treatment anxiolytic or hypnotic treatment initiated or increased during the previous month general anaesthesia during the previous 3 months history of heart surgery with cardiopulmonary bypass comorbidities affecting cognition (respiratory, renal, liver, heart failure…) women of childbearing potential (defined as pre-menopausal, less than 2 years postmenopausal, or not surgically sterile) persons placed under judicial protection Patients : contraindication to MRI Controls: deficit on MMSE <27

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients<br>battery of tests of social cognition | Behavioral: social cognition<br>* battery of tests of social cognition<br>|
| Active Comparator: Control<br>battery of tests of social cognition | Behavioral: social cognition<br>* battery of tests of social cognition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tests of social cognition (questionnaire) | standardize and validate in French-speaking population a comprehensive battery of tests of social cognition | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, Alzheimer, Disorders of socio-emotional, frontal temporal dementia, Parkinson, Huntington, traumatic brain injury, focal lesions