- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01315405
Facial Expression Recognition and Mirror Neurons in Parkinson's Disease
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)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Clermont-FERRAND, France, 63003
- Recruiting
- Chu Clermont-Ferrand
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Contact:
- Patrick LACARIN
- Phone Number: 04 73 75 11 95
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Free from any visio-perceptive disorder (visual acuity and Vitec)
- Affiliated to National Health system
- Having given their informed consent
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Measurement of facial electromyographic activity during emotional facial expression recognition tests
Time Frame: at J0 and at J+15 days
|
at J0 and at J+15 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Measurement of facial electromyographic activity during voluntary facial mimicking
Time Frame: at J0 and at J+15days
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at J0 and at J+15days
|
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Measurement of facial electromyographic activity during emotional movies viewing
Time Frame: Made at J0 and at J+15days
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Made at J0 and at J+15days
|
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Measurement of Empathy (Baron-Cohen), Apathy (Starkstein)
Time Frame: Made at J0 and at J+15days
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Made at J0 and at J+15days
|
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Measurement of the effect of Levodopa on these parameters
Time Frame: Made at J0 and at J+15days
|
Made at J0 and at J+15days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ana MARQUES, PH, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-0090
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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