Parkinson's DiseaseNCT01315405
Facial Expression Recognition and Mirror Neurons in Parkinson's Disease
A study testing Emotional facial expression recognition tests in people with Parkinson's Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
After few years of evolution, patients with Parkinson's disease may develop apathy, with different degrees of severity. Apathy is characterized by a loss of interest for the others and for activities. The lack of social interactions in these patients may be due to an impairment in decoding emotional facial expression. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Emotional facial expression recognition tests
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to Jul 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with idiopathic Parkinson's disease according to UKPDSBB criteria - Men or women aged between 18 to 75 years
- Free from any visio-perceptive disorder (visual acuity and Vitec)
- Affiliated to National Health system
- Having given their informed consent
- --Healthy controls
- Men or women aged between 18 to 75 years
Show all 9Show fewer
- Free from any visio-perceptive disorder (visual acuity and Vitec)
- Affiliated to National Health system
- Having given their informed consent
Who cannot join
- With dementia or with significant dysexecutive disorder (MMS <24, MATTIS< 130)
- With fluctuations (<5 Levodopa intakes / day)
- With severe depression (BDI > 27)
- With psychiatric comorbidities (hallucinations, psychos) evaluated with l'Unified Parkinson's disease Rating Scale part I (UPDRS part I =0)
- With faces processing disorder (Benton < 39)
- Pregnant
Show all 15Show fewer
- Treatment with deep brain stimulation
- Under guardianship
- In excluding period for another study
- --Healthy controls
- Suffering of neurological or psychiatric evolutive condition
- With severe depression (BDI > 27)
- With faces processing disorder (Benton < 39)
- Pregnant
- In excluding period for another study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95
About this study
Official title: Do Facial Expression Recognition Disorder and Mirror Neurons Subtend Apathy in Parkinson's Disease?
After few years of evolution, patients with Parkinson's disease may develop apathy, with different degrees of severity. Apathy is characterized by a loss of interest for the others and for activities. The lack of social interactions in these patients may be due to an impairment in decoding emotional facial expression. Indeed, facial expression recognition, which is necessary to understand other's emotional state, requires a subclinical facial mimicking of the expression observed. Yet, one of the clinical signs of PD is amimia.
This study aims to determinate if there is a facial mimicry disorder in PD ( Parkinson's disease )patients with emotional facial expression (EFE) recognition impairment, compared to healthy control subjects. We also want to know if this facial mimicry disorder is primary (subtended by facial mobility impairment, that is to say amimia) or secondary (related to the mirror neuron systems that allows us to activate similar neural networks when observing and feeling a specific emotion)
Read the detailed description
20 patients with an Idiopathic Parkinson's disease
+ 20 paired healthy volunteers (on sex, age, and education)
After inclusion, patients are evaluated two times: they are studied without medication (MED OFF) and with medication (STIM ON) in a randomized order. The 2 evaluations should be spaced out 15 days to one month (J0 and J+15d)
Healthy subjects have only one visit J0 (inclusion and emotional facial expression recognition tests are made at the same time)
- Conditions
- Parkinson's Disease
- Being tested
- Emotional facial expression recognition tests
- Keywords
- Emotional facial expression, Apathy, Mirror neurons
- Medical subject headings
- Parkinson Disease, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional facial expression recognition testsBehavioural
20 patients with an Idiopathic Parkinson's disease
+ 20 paired healthy volunteers (on sex, age, and education)
After inclusion, patients are evaluated two times: they are studied without medication (MED OFF) and with medication (STIM ON) in a randomized order. The 2 evaluations should be spaced out 15 days to one month (J0 and J+15d)
Healthy subjects have only one visit J0 (inclusion and emotional facial expression recognition tests are made at the same time)
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of facial electromyographic activity during emotional facial expression recognition tests
Measured: at J0 and at J+15 days
Secondary outcomes (4)
Measurement of facial electromyographic activity during voluntary facial mimicking
Measured: at J0 and at J+15days
Measurement of facial electromyographic activity during emotional movies viewing
Measured: Made at J0 and at J+15days
Measurement of Empathy (Baron-Cohen), Apathy (Starkstein)
Measured: Made at J0 and at J+15days
Measurement of the effect of Levodopa on these parameters
Measured: Made at J0 and at J+15days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2012 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Ana MARQUES, PH, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315405
- Sponsor's protocol ID
- CHU-0090
- Status last verified
- Mar 2011
- First submitted
- 28 Feb 2011
- Last updated
- 16 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Facial Expression Recognition Disorder and Mirror Neurons Subtend Apathy in Parkinson's Disease?
- ClinicalTrials.gov ID
- NCT01315405
- Acronym / sponsor ID
- CHU-0090
- Conditions
- Parkinson's Disease
- Keywords
- Emotional facial expression, Apathy, Mirror neurons
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 15 Mar 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.
After few years of evolution, patients with Parkinson's disease may develop apathy, with different degrees of severity. Apathy is characterized by a loss of interest for the others and for activities. The lack of social interactions in these patients may be due to an impairment in decoding emotional facial expression. Indeed, facial expression recognition, which is necessary to understand other's emotional state, requires a subclinical facial mimicking of the expression observed. Yet, one of the clinical signs of PD is amimia.
This study aims to determinate if there is a facial mimicry disorder in PD ( Parkinson's disease )patients with emotional facial expression (EFE) recognition impairment, compared to healthy control subjects. We also want to know if this facial mimicry disorder is primary (subtended by facial mobility impairment, that is to say amimia) or secondary (related to the mirror neuron systems that allows us to activate similar neural networks when observing and feeling a specific emotion)
Detailed description
20 patients with an Idiopathic Parkinson's disease
+ 20 paired healthy volunteers (on sex, age, and education)
After inclusion, patients are evaluated two times: they are studied without medication (MED OFF) and with medication (STIM ON) in a randomized order. The 2 evaluations should be spaced out 15 days to one month (J0 and J+15d)
Healthy subjects have only one visit J0 (inclusion and emotional facial expression recognition tests are made at the same time)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with idiopathic Parkinson's disease according to UKPDSBB criteria - Men or women aged between 18 to 75 years
- Free from any visio-perceptive disorder (visual acuity and Vitec)
- Affiliated to National Health system
- Having given their informed consent
- --Healthy controls
Key exclusion criteria (15 listed)
- With dementia or with significant dysexecutive disorder (MMS <24, MATTIS< 130)
- With fluctuations (<5 Levodopa intakes / day)
- With severe depression (BDI > 27)
- With psychiatric comorbidities (hallucinations, psychos) evaluated with l'Unified Parkinson's disease Rating Scale part I (UPDRS part I =0)
- With faces processing disorder (Benton < 39)
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 |
|---|---|---|
| Emotional facial expression recognition tests20 patients with an Idiopathic Parkinson's disease + 20 paired healthy volunteers (on sex, age, and education) After inclusion, patients are evaluated two times: they are studied without medication (MED OFF) and with medication (STIM ON) in a randomized order. The 2 evaluations should be spaced out 15 days to one month (J0 and J+15d) Healthy subjects have only one visit J0 (inclusion and emotional facial expression recognition tests are made at the same time) | Behavioural | – |
Primary outcome
Measurement of facial electromyographic activity during emotional facial expression recognition tests
Time frame: at J0 and at J+15 days
4 secondary outcomes
Measurement of facial electromyographic activity during voluntary facial mimicking
Time frame: at J0 and at J+15days
Measurement of facial electromyographic activity during emotional movies viewing
Time frame: Made at J0 and at J+15days
Measurement of Empathy (Baron-Cohen), Apathy (Starkstein)
Time frame: Made at J0 and at J+15days
Measurement of the effect of Levodopa on these parameters
Time frame: Made at J0 and at J+15days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2011.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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.
Ana MARQUES, PH principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional facial expression recognition tests in people with Parkinson's Disease, run by University Hospital, Clermont-Ferrand 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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 16 Mar 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of facial electromyographic activity during emotional facial expression recognition tests (time frame: at J0 and at J+15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2011; AzTrials last refreshed its copy on 7 Nov 2026.