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

March 31, 2011
December 1, 2011
June 2009
June 2013   (final data collection date for primary outcome measure)
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')
Same as current
Complete list of historical versions of study NCT01339130 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Assessment of Social-emotional Functioning in Neurological Diseases
Assessment of Social-emotional Functioning in Stroke, Frontotemporal Dementia, Alzheimer and Parkinson Diseases

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.

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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Alzheimer Disease
  • Stroke
  • Parkinson's Disease
  • Lewy Body Dementia
  • Huntington Disease
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.
behavioral and physiological tests
Computerized tests and Electrophysiological measurements
Intervention: Behavioral: Computerized tests and Electrophysiological measurements
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
320
June 2013
June 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 85 Years
Yes
Contact: Olivier Godefroy, PhD-MD ++33 322668240 godefroy.olivier@chu-amiens.fr
Contact: Mouras Harold, PhD ++33 322825442 Harold.Mouras@u-picardie.fr
France
 
NCT01339130
PI09-PR-GODEFROY, 2009-A00596-51
No
Centre Hospitalier Universitaire, Amiens
Centre Hospitalier Universitaire, Amiens
Not Provided
Study Chair: Olivier Godefroy, PhD-MD CHU Amiens
Centre Hospitalier Universitaire, Amiens
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP