Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies (GREFEXII)
Primary Purpose
Alzheimer Disease, Parkinson Disease, Frontal Dementia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
social cognition
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Disorders of socio-emotional, Alzheimer, frontal temporal dementia, Parkinson, Huntington, traumatic brain injury, stroke, focal lesions
Eligibility Criteria
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
Controls:
derived from the general population and consenting to participate in the study
Patients:
- MMS>18
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:
- 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
- ongoing antidepressant or antiepileptic treatment
- anxiolytic or hypnotic treatment initiated or increased during the previous month
- general anaesthesia during the previous 3 months
- history of heart surgery with cardiopulmonary bypass
- comorbidities affecting cognition (respiratory, renal, liver, heart failure…)
- women of childbearing potential (defined as pre-menopausal, less than 2 years postmenopausal, or not surgically sterile)
persons placed under judicial protection
Patients :
contraindication to MRI
Controls:
- deficit on MMSE <27
Sites / Locations
- CHU Amiens
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients
Control
Arm Description
battery of tests of social cognition
battery of tests of social cognition
Outcomes
Primary Outcome Measures
tests of social cognition (questionnaire)
standardize and validate in French-speaking population a comprehensive battery of tests of social cognition
Secondary Outcome Measures
Full Information
NCT ID
NCT03052712
First Posted
February 7, 2017
Last Updated
October 17, 2019
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03052712
Brief Title
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
Acronym
GREFEXII
Official Title
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
not enough patients
Study Start Date
September 9, 2016 (Actual)
Primary Completion Date
September 8, 2019 (Actual)
Study Completion Date
September 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Active Comparator
Arm Description
battery of tests of social cognition
Arm Title
Control
Arm Type
Active Comparator
Arm Description
battery of tests of social cognition
Intervention Type
Behavioral
Intervention Name(s)
social cognition
Intervention Description
battery of tests of social cognition
Primary Outcome Measure Information:
Title
tests of social cognition (questionnaire)
Description
standardize and validate in French-speaking population a comprehensive battery of tests of social cognition
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Controls:
derived from the general population and consenting to participate in the study
Patients:
MMS>18
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:
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
ongoing antidepressant or antiepileptic treatment
anxiolytic or hypnotic treatment initiated or increased during the previous month
general anaesthesia during the previous 3 months
history of heart surgery with cardiopulmonary bypass
comorbidities affecting cognition (respiratory, renal, liver, heart failure…)
women of childbearing potential (defined as pre-menopausal, less than 2 years postmenopausal, or not surgically sterile)
persons placed under judicial protection
Patients :
contraindication to MRI
Controls:
deficit on MMSE <27
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier GODEFROY, MD, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Learn more about this trial
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
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