Assessment of Social-emotional Functioning in Neurological Diseases (Emotion)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01339130
First received: March 31, 2011
Last updated: December 1, 2011
Last verified: April 2011
  Purpose

Empathy, defined as the ability to understand others emotions, is a fundamental concept in social interactions. It is a psychological phenomenon involving various separable components : (i) the ability to feel and imagine the emotions, (ii) the ability to adopt the perspective of other people. Several neurological diseases with behavioral disorders may lead to impaired processing of social and/or emotional informations. These pathologies are likely to induce a lack of empathy that may result from impairments at different levels.

The objective is simply to study how others' emotions are understood and how this allows for regulation of personal behavior. This study is being carried out among patients seen for various health problems and who can make behavior changes. This study could help to understand some neurological diseases and thereby to identify them earlier and/or to better differentiate them.


Condition Intervention
Alzheimer Disease
Stroke
Parkinson's Disease
Lewy Body Dementia
Huntington Disease
Behavioral: Computerized tests and Electrophysiological measurements

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of Social-emotional Functioning in Stroke, Frontotemporal Dementia, Alzheimer and Parkinson Diseases

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Empathy ability [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Empathy ability is a composite index associating performance on 3 tests (Facial emotion recognition, Theory of Mind and 'Faux pas')


Secondary Outcome Measures:
  • Empathy for pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    pain rating on pictures when others are involved

  • pattern of empathy disorders according to the disease (stroke, Mild cognitive impairment, Alzheimer disease and Parkinson disease [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: June 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
behavioral and physiological tests
Computerized tests and Electrophysiological measurements
Behavioral: Computerized tests and Electrophysiological measurements
  • Computerized tests: used to evaluate the empathy The participant observes a computer screen on which appears different types of images or words that can evoke an emotion. The participant responds by pressing the screen with his finger. This is a choice between several answers and respond as quickly as possible.
  • Electrophysiological measurements: provide a measure of autonomic response to emotional stimuli: galvanic response (GSR) and electromyographic activity (EMG) of facial muscles (corrugator supercilii and zygomatic major).
  • Neuropsychological assessment includes an assessment of intellectual efficiency, perceptual and visual-constructive abilities, memory, executive and an assessment of behavior and mood from questionnaires.

Detailed Description:

Empathy is a fundamental concept in social interactions, whose function is to understand the emotions felt by others. According to De Waal (2008), it is a multidimensional concept that involves two processes :(i) a system of emotional contagion or affective resonance (the unconscious and automatic sharing of the emotion of others) that establishes the emotional component of empathy, (ii) the ability to take perspective, that is the ability to imagine the subjective world of the other distinguishing oneself from him, forming the cognitive component of empathy.

Several neurological diseases with behavioral disorders may lead to impaired processing of social and/or emotional information. These pathologies are likely to induce a lack of empathy that may result from impairments at different levels.

The main objective of this study is to examine empathy in patients suffering from stroke (various locations with an emphasis on frontal stroke), Fronto-temporal dementia, Alzheimer and Parkinson diseases. The final assessment criterion is the overall score on the scale of empathy.

The patient will firstly receive a medical examination and clinical data are collected (past medical history, clinical neurological examination, diagnosis, description of first symptoms, course, current treatments)and brain imaging data. After checking inclusion criteria, information letter and the consent form will be returned.

The second visit will consist in neuropsychological assessment: general intellectual efficiency, perceptual and visual-constructive abilities, memory, executive and an assessment of behavior and mood from questionnaires The third and final visit will allow passing experimental tests. The experimental part will include the following tests: (1) recognition of emotional facial expressions; (2) tasks of theory of mind ; (3) task of empathy for pain.

A control group will also perform the neuropsychological and experimental tests.

The duration of the study participation for eligible patients and controls will vary according to the delay between each visit (medical, neuropsychological and experimental) and is lower than 3 months. The study will take place from June 2009 to June 2013.

  • Number of patients: 320
  • Number of controls: 400
  • Potential Benefits expected: criteria for early diagnosis and / or differential diagnosis based on the evaluation process of empathy; elaboration of new clinical tools assisting diagnosis.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (Controls):

  • being over 18 years old
  • speaking French
  • in good general health
  • affiliated to a welfare state
  • given their informed consent in writing

Inclusion Criteria (Patients):

  • 18 to 85 years old
  • French speaker
  • affiliated to a Welfare state
  • written consent
  • MMSE> 20
  • no alexia, agraphia or illiteracy
  • absence of diseases that can interfere with cognition (neoplasia, chronic alcoholism ...) of current or past neurological diseases other than those which justified the support nervous system (meningitis, encephalitis, brain injury, developmental disorders, deficits sensory or motor, epilepsy requiring treatment today ...), or of psychiatric disorder (except depression treated)

Exclusion Criteria (controls):

  • pathological MMSE score
  • insufficient acquisition of the alphabet
  • reading, writing, arithmetic
  • the presence of a visual deficit or hearing deficit disturbing the tests, paralysis of the dominant hand
  • the presence of brain pathology interfering, neurological or psychiatric history

Exclusion Criteria (Patients):

  • difficulties in reading, writing or illiteracy
  • diseases that can interfere with cognition (neoplasia, chronic alcoholism ...)
  • current or past neurological diseases other than those which justified the neurological consultation, Psychiatric pathology (except depression treated)
  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: NCT01339130

Contacts
Contact: Olivier Godefroy, PhD-MD ++33 322668240 godefroy.olivier@chu-amiens.fr
Contact: Mouras Harold, PhD ++33 322825442 Harold.Mouras@u-picardie.fr

Locations
France
CHU Amiens Recruiting
Amiens, Picardie, France, 80000
Contact: Olivier Godefroy, PhD-MD    ++33322668240    olivier.godefroy@chu-amiens.fr   
Contact: Harold Mouras, PhD    +33 3 22 82 54 42    Harold.Mouras@u-picardie.fr   
Sub-Investigator: Pierre Krystkowiak, PhD-MD         
Principal Investigator: Olivier Godefroy, PhD-MD         
Sub-Investigator: Gwenole Loas, PhD-MD         
Sub-Investigator: Harold Mouras, PhD         
Sub-Investigator: Martine Roussel, PhD         
Sub-Investigator: Pauline Narme, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Study Chair: Olivier Godefroy, PhD-MD CHU Amiens
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01339130     History of Changes
Other Study ID Numbers: PI09-PR-GODEFROY, 2009-A00596-51
Study First Received: March 31, 2011
Last Updated: December 1, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Alzheimer disease
Stroke
Frontotemporal Lobar Degeneration
Lewy Body Dementia
Huntington Disease
mild cognitive impairment
vascular injury
Parkinson's disease

Additional relevant MeSH terms:
Huntington Disease
Alzheimer Disease
Dementia
Nervous System Diseases
Parkinson Disease
Stroke
Cerebral Infarction
Frontotemporal Dementia
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Basal Ganglia Diseases
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Cognition Disorders
Parkinsonian Disorders
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on July 31, 2014