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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
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

First Posted
February 7, 2017
Last Updated
October 17, 2019
Sponsor
Centre Hospitalier Universitaire, Amiens
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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

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

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