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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03052712
Recruitment Status : Terminated (not enough patients)
First Posted : February 14, 2017
Last Update Posted : October 21, 2019
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Parkinson Disease Frontal Dementia Huntington Disease Traumatic Brain Injury Stroke Behavioral: social cognition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
Actual Study Start Date : September 9, 2016
Actual Primary Completion Date : September 8, 2019
Actual Study Completion Date : September 8, 2019

Arm Intervention/treatment
Active Comparator: Patients
battery of tests of social cognition
Behavioral: social cognition
battery of tests of social cognition

Active Comparator: Control
battery of tests of social cognition
Behavioral: social cognition
battery of tests of social cognition

Primary Outcome Measures :
  1. tests of social cognition (questionnaire) [ Time Frame: 3 years ]
    standardize and validate in French-speaking population a comprehensive battery of tests of social cognition

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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


  5. derived from the general population and consenting to participate in the study


  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


  17. deficit on MMSE <27

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052712

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CHU Amiens
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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Principal Investigator: Olivier GODEFROY, MD, PhD CHU Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03052712    
Other Study ID Numbers: PI2015_843_0031
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Disorders of socio-emotional
frontal temporal dementia
traumatic brain injury
focal lesions
Additional relevant MeSH terms:
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Parkinson Disease
Alzheimer Disease
Brain Injuries
Brain Injuries, Traumatic
Huntington Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Cognition Disorders