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

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: NCT01339130
Recruitment Status : Completed
First Posted : April 20, 2011
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Alzheimer Disease Stroke Parkinson's Disease Lewy Body Dementia Huntington Disease Behavioral: Computerized tests and Electrophysiological measurements Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Social-emotional Functioning in Stroke, Frontotemporal Dementia, Alzheimer and Parkinson Diseases
Study Start Date : June 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Empathy ability [ Time Frame: 3 months ]
    Empathy ability is a composite index associating performance on 3 tests (Facial emotion recognition, Theory of Mind and 'Faux pas')


Secondary Outcome Measures :
  1. Empathy for pain [ Time Frame: 3 months ]
    pain rating on pictures when others are involved

  2. pattern of empathy disorders according to the disease (stroke, Mild cognitive impairment, Alzheimer disease and Parkinson disease [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT01339130


Locations
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France
CHU Amiens
Amiens, Picardie, France, 80000
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Study Chair: Olivier Godefroy, PhD-MD CHU Amiens
More Information
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Publications of Results:

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01339130    
Other Study ID Numbers: PI09-PR-GODEFROY
2009-A00596-51 ( Other Identifier: CHU )
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: September 7, 2015
Last Verified: September 2015
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:
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Stroke
Parkinson Disease
Alzheimer Disease
Dementia
Huntington Disease
Lewy Body Disease
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Parkinsonian Disorders
 Basal Ganglia Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders
Chorea
Dyskinesias
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Cognition Disorders