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Facial Expression Recognition and Mirror Neurons in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Emotional facial expression recognition tests

About this trial

This is an interventional diagnostic trial for Parkinson's Disease focused on measuring Emotional facial expression, Apathy, Mirror neurons

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CHU Clermont-FerrandRecruiting

Outcomes

Primary Outcome Measures

Measurement of facial electromyographic activity during emotional facial expression recognition tests

Secondary Outcome Measures

Measurement of facial electromyographic activity during voluntary facial mimicking

Measurement of facial electromyographic activity during emotional movies viewing

Measurement of Empathy (Baron-Cohen), Apathy (Starkstein)

Measurement of the effect of Levodopa on these parameters

Full Information

NCT ID

NCT01315405

First Posted

February 28, 2011

Last Updated

March 15, 2011

Sponsor

University Hospital, Clermont-Ferrand

1. Study Identification

Unique Protocol Identification Number

NCT01315405

Brief Title

Facial Expression Recognition and Mirror Neurons in Parkinson's Disease

Official Title

Do Facial Expression Recognition Disorder and Mirror Neurons Subtend Apathy in Parkinson's Disease?

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Unknown status

Study Start Date

July 2010 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

July 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

Brief 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. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

Emotional facial expression, Apathy, Mirror neurons

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Emotional facial expression recognition tests

Intervention Description

Primary Outcome Measure Information:

Title

Measurement of facial electromyographic activity during emotional facial expression recognition tests

Time Frame

at J0 and at J+15 days

Secondary Outcome Measure Information:

Title

Measurement of facial electromyographic activity during voluntary facial mimicking

Time Frame

at J0 and at J+15days

Title

Measurement of facial electromyographic activity during emotional movies viewing

Time Frame

Made at J0 and at J+15days

Title

Measurement of Empathy (Baron-Cohen), Apathy (Starkstein)

Time Frame

Made at J0 and at J+15days

Title

Measurement of the effect of Levodopa on these parameters

Time Frame

Made at J0 and at J+15days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana MARQUES, PH

Organizational Affiliation

University Hospital, Clermont-Ferrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Clermont-Ferrand

City

Clermont-FERRAND

ZIP/Postal Code

63003

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick LACARIN

Phone

04 73 75 11 95

12. IPD Sharing Statement

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Facial Expression Recognition and Mirror Neurons in Parkinson's Disease

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