Clinical trial NCT03052712: Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
Official title: Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease
Parkinson Disease
Frontal Dementia
Huntington Disease
Traumatic Brain Injury
Stroke
Keywords: Disorders of socio-emotional
Alzheimer
frontal temporal dementia
Parkinson
Huntington
traumatic brain injury
stroke
focal lesions
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: tests of social cognition (questionnaire)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Olivier GODEFROY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: