NCT01339130

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

4 years

First QC Date

March 31, 2011

Last Update Submit

September 4, 2015

Conditions

Keywords

Alzheimer diseaseStrokeFrontotemporal Lobar DegenerationLewy Body DementiaHuntington Diseasemild cognitive impairmentvascular injuryParkinson's disease

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

OTHER

Computerized tests and Electrophysiological measurements

Behavioral: Computerized 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.

behavioral and physiological tests

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

  • 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.

MeSH Terms

Conditions

Alzheimer DiseaseStrokeParkinson DiseaseLewy Body DiseaseHuntington DiseaseFrontotemporal Lobar DegenerationCognitive DysfunctionVascular System Injuries

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesChoreaDyskinesiasHeredodegenerative Disorders, Nervous SystemGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersTDP-43 ProteinopathiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and Injuries

Study Officials

  • Olivier Godefroy, PhD-MD

    CHU Amiens

    STUDY CHAIR

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

Locations