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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03052712
Acronym
GREFEXII
Enrollment
44
Registered
2017-02-14
Start date
2016-09-09
Completion date
2019-09-08
Last updated
2019-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Disorders of socio-emotional, Alzheimer, frontal temporal dementia, Parkinson, Huntington, traumatic brain injury, stroke, focal lesions

Brief 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.

Interventions

BEHAVIORALsocial cognition

battery of tests of social cognition

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

1. Provision of signed and dated informed consent form (ICF) 2. Male or female, aged 20 to 80 years inclusive at the time of signing ICF 3. French-speaking 4. reliable informant Controls: 5. derived from the general population and consenting to participate in the study Patients: 6. MMS\>18 7. 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

1. Illiteracy 2. mental retardation 3. visual or motor deficit preventing reading, drawing or writing (scores on the reading, drawing or sentence writing subtests of the MMSE = 0) 4. hearing impairment interfering with understanding of instructions, 5. 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 6. 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 7. alcoholism (mean alcohol consumption \> 3 standard drinks/day or history of alcohol withdrawal) 8. use of opiates or other illicit drugs during the previous 3 months or causing withdrawal syndrome 9. ongoing antidepressant or antiepileptic treatment 10. anxiolytic or hypnotic treatment initiated or increased during the previous month 11. general anaesthesia during the previous 3 months 12. history of heart surgery with cardiopulmonary bypass 13. comorbidities affecting cognition (respiratory, renal, liver, heart failure…) 14. women of childbearing potential (defined as pre-menopausal, less than 2 years postmenopausal, or not surgically sterile) 15. persons placed under judicial protection Patients : 16. contraindication to MRI Controls: 17. deficit on MMSE \<27

Design outcomes

Primary

MeasureTime frameDescription
tests of social cognition (questionnaire)3 yearsstandardize and validate in French-speaking population a comprehensive battery of tests of social cognition

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026