Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Variou… (NCT03052712) | Clinical Trial Compass
TerminatedNot Applicable
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
Stopped: not enough patients
France44 participantsStarted 2016-09-09
Plain-language summary
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.
Who can participate
Age range20 Years – 80 Years
SexALL
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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
✓. derived from the general population and consenting to participate in the study
✓. MMS\>18
✓. Patients followed for mild or major neurocognitive disorder related to :
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