Assessment of Social-emotional Functioning in Neurological Diseases (Emotion)
Primary Purpose
Alzheimer Disease, Stroke, Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Computerized tests and Electrophysiological measurements
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Alzheimer disease, Stroke, Frontotemporal Lobar Degeneration, Lewy Body Dementia, Huntington Disease, mild cognitive impairment, vascular injury, Parkinson's disease
Eligibility 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)
Sites / Locations
- CHU Amiens
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
behavioral and physiological tests
Arm Description
Computerized tests and Electrophysiological measurements
Outcomes
Primary Outcome Measures
Empathy ability
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
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
Full Information
NCT ID
NCT01339130
First Posted
March 31, 2011
Last Updated
September 4, 2015
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT01339130
Brief Title
Assessment of Social-emotional Functioning in Neurological Diseases
Acronym
Emotion
Official Title
Assessment of Social-emotional Functioning in Stroke, Frontotemporal Dementia, Alzheimer and Parkinson Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Stroke, Parkinson's Disease, Lewy Body Dementia, Huntington Disease
Keywords
Alzheimer disease, Stroke, Frontotemporal Lobar Degeneration, Lewy Body Dementia, Huntington Disease, mild cognitive impairment, vascular injury, Parkinson's disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
behavioral and physiological tests
Arm Type
Other
Arm Description
Computerized tests and Electrophysiological measurements
Intervention Type
Behavioral
Intervention Name(s)
Computerized tests and Electrophysiological measurements
Intervention Description
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.
Primary Outcome Measure Information:
Title
Empathy ability
Description
Empathy ability is a composite index associating performance on 3 tests (Facial emotion recognition, Theory of Mind and 'Faux pas')
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Empathy for pain
Description
pain rating on pictures when others are involved
Time Frame
3 months
Title
pattern of empathy disorders according to the disease (stroke, Mild cognitive impairment, Alzheimer disease and Parkinson disease
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Godefroy, PhD-MD
Organizational Affiliation
CHU Amiens
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Amiens
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
23930667
Citation
Narme P, Mouras H, Roussel M, Devendeville A, Godefroy O. Assessment of socioemotional processes facilitates the distinction between frontotemporal lobar degeneration and Alzheimer's disease. J Clin Exp Neuropsychol. 2013;35(7):728-44. doi: 10.1080/13803395.2013.823911. Epub 2013 Aug 12.
Results Reference
result
PubMed Identifier
23527646
Citation
Narme P, Mouras H, Roussel M, Duru C, Krystkowiak P, Godefroy O. Emotional and cognitive social processes are impaired in Parkinson's disease and are related to behavioral disorders. Neuropsychology. 2013 Mar;27(2):182-92. doi: 10.1037/a0031522.
Results Reference
result
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Assessment of Social-emotional Functioning in Neurological Diseases
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