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

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Centre Hospitalier Universitaire, Amiens
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT03052712
First received: February 7, 2017
Last updated: February 10, 2017
Last verified: February 2017
  Purpose
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 Intervention
Alzheimer Disease Parkinson Disease Frontal Dementia Huntington Disease Traumatic Brain Injury Stroke Behavioral: social cognition

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Diagnostic
Official Title: Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies (GREFEX II)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

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


Estimated Enrollment: 1170
Actual Study Start Date: November 13, 2015
Estimated Study Completion Date: November 13, 2018
Estimated Primary Completion Date: November 13, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03052712

Contacts
Contact: Olivier GODEFROY, MD, PhD +33 3 22 66 82 40 godefroy.olivier@chu-amiens.fr

Locations
France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Olivier GODEFROY, MD, PhD    +33 3 22 66 82 40    godefroy.olivier@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Olivier GODEFROY, MD, PhD CHU Amiens
  More Information

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03052712     History of Changes
Other Study ID Numbers: PI2015_843_0031
Study First Received: February 7, 2017
Last Updated: February 10, 2017

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
Alzheimer
frontal temporal dementia
Parkinson
Huntington
traumatic brain injury
stroke
focal lesions

Additional relevant MeSH terms:
Parkinson Disease
Alzheimer Disease
Brain Injuries
Dementia
Huntington Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Chorea
Dyskinesias
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Cognition Disorders

ClinicalTrials.gov processed this record on July 24, 2017