Facial Expression Recognition and Mirror Neurons in Parkinson's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01315405
First received: February 28, 2011
Last updated: March 15, 2011
Last verified: March 2011
  Purpose

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)


Condition Intervention
Parkinson's Disease
Behavioral: Emotional facial expression recognition tests

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Do Facial Expression Recognition Disorder and Mirror Neurons Subtend Apathy in Parkinson's Disease?

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Measurement of facial electromyographic activity during emotional facial expression recognition tests [ Time Frame: at J0 and at J+15 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measurement of facial electromyographic activity during voluntary facial mimicking [ Time Frame: at J0 and at J+15days ] [ Designated as safety issue: Yes ]
  • Measurement of facial electromyographic activity during emotional movies viewing [ Time Frame: Made at J0 and at J+15days ] [ Designated as safety issue: Yes ]
  • Measurement of Empathy (Baron-Cohen), Apathy (Starkstein) [ Time Frame: Made at J0 and at J+15days ] [ Designated as safety issue: Yes ]
  • Measurement of the effect of Levodopa on these parameters [ Time Frame: Made at J0 and at J+15days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Emotional facial expression recognition tests

    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)

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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315405

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-FERRAND, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95      
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Ana MARQUES, PH University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01315405     History of Changes
Other Study ID Numbers: CHU-0090
Study First Received: February 28, 2011
Last Updated: March 15, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Emotional facial expression
Apathy
Mirror neurons

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 18, 2014