Alzheimer DiseaseEmotionNCT01339130
Assessment of Social-emotional Functioning in Neurological Diseases
A study testing Computerized tests and Electrophysiological measurements in people with Alzheimer Disease and Stroke, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Stroke, Parkinson's Disease
- What is being tested?
- Computerized tests and Electrophysiological measurements
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being over 18 years old
- speaking French
- in good general health
- affiliated to a welfare state
- given their informed consent in writing
- 18 to 85 years old
Show all 12Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Computerized tests and Electrophysiological measurements
- Keywords
- Alzheimer disease, Stroke, Frontotemporal Lobar Degeneration, Lewy Body Dementia, Huntington Disease, mild cognitive impairment, vascular injury, Parkinson's disease
- Medical subject headings
- Alzheimer Disease, Stroke, Parkinson Disease, Lewy Body Disease, Huntington Disease, Frontotemporal Lobar Degeneration, Cognitive Dysfunction, Vascular System Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized tests and Electrophysiological measurementsBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| behavioral and physiological tests | Other | Computerized tests and Electrophysiological measurements Receives: Behavioral: Computerized tests and Electrophysiological measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Empathy ability
Empathy ability is a composite index associating performance on 3 tests (Facial emotion recognition, Theory of Mind and 'Faux pas')
Measured: 3 months
Secondary outcomes (2)
Empathy for pain
pain rating on pictures when others are involved
Measured: 3 months
pattern of empathy disorders according to the disease (stroke, Mild cognitive impairment, Alzheimer disease and Parkinson disease
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startJun 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Godefroy, PhD-MD, Study chair, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339130
- Sponsor's protocol ID
- PI09-PR-GODEFROY
- Other IDs
- 2009-A00596-51
- Acronym
- Emotion
- Status last verified
- Sep 2015
- First submitted
- 31 Mar 2011
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23930667Narme 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.
PubMed 23527646
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Social-emotional Functioning in Stroke, Frontotemporal Dementia, Alzheimer and Parkinson Diseases
- ClinicalTrials.gov ID
- NCT01339130
- Acronym / sponsor ID
- Emotion / PI09-PR-GODEFROY
- Keywords
- Alzheimer disease, Stroke, Frontotemporal Lobar Degeneration, Lewy Body Dementia, Huntington Disease, mild cognitive impairment, vascular injury, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| behavioral and physiological tests | Other | Behavioral: Computerized tests and Electrophysiological measurementsComputerized tests and Electrophysiological measurements |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- being over 18 years old
- speaking French
- in good general health
- affiliated to a welfare state
- given their informed consent in writing
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | behavioral and physiological tests |
Primary outcome
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')
2 secondary outcomes
Empathy for pain
Time frame: 3 months
pattern of empathy disorders according to the disease (stroke, Mild cognitive impairment, Alzheimer disease and Parkinson disease
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Results publication: PubMed 23930667Narme 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 publication: PubMed 23527646Narme 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Godefroy, PhD-MD study chair
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized tests and Electrophysiological measurements in people with Alzheimer Disease and Stroke, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Empathy ability (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01339130, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2015.