Assessment of Social-emotional Functioning in Neurological Diseases
Emotion
2 other identifiers
interventional
177
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable alzheimer-disease
Started Jun 2009
Longer than P75 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 31, 2011
CompletedFirst Posted
Study publicly available on registry
April 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedSeptember 7, 2015
September 1, 2015
4 years
March 31, 2011
September 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Empathy ability
Empathy ability is a composite index associating performance on 3 tests (Facial emotion recognition, Theory of Mind and 'Faux pas')
3 months
Secondary Outcomes (2)
Empathy for pain
3 months
pattern of empathy disorders according to the disease (stroke, Mild cognitive impairment, Alzheimer disease and Parkinson disease
3 months
Study Arms (1)
behavioral and physiological tests
OTHERComputerized tests and Electrophysiological measurements
Interventions
* 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.
Eligibility Criteria
You may qualify if:
- being over 18 years old
- speaking French
- in good general health
- affiliated to a welfare state
- given their informed consent in writing
- 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)
You may not qualify if:
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, Picardie, 80000, France
Related Publications (2)
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.
PMID: 23930667RESULTNarme 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.
PMID: 23527646RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Olivier Godefroy, PhD-MD
CHU Amiens
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2011
First Posted
April 20, 2011
Study Start
June 1, 2009
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
September 7, 2015
Record last verified: 2015-09