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

Stroke Clinical Trial

— GREFEXII  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03052712
• Other study ID #: PI2015_843_0031
• Status: Terminated
• Phase: N/A
• Start date: September 9, 2016
• Est. completion date: September 8, 2019

Study information

• Verified date: October 2019
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: September 8, 2019
• Est. primary completion date: September 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• social cognition
battery of tests of social cognition

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tests of social cognition (questionnaire)	standardize and validate in French-speaking population a comprehensive battery of tests of social cognition	3 years