Facial Expression Recognition and Mirror Neurons in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01315405
• Other study ID #: CHU-0090
• Status: Recruiting
• Phase: N/A
• First received: February 28, 2011
• Last updated: March 15, 2011
• Start date: July 2010
• Est. completion date: July 2013

Study information

• Verified date: March 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical 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. 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)

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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)

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-FERRAND

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of facial electromyographic activity during emotional facial expression recognition tests		at J0 and at J+15 days	Yes
Secondary	Measurement of facial electromyographic activity during voluntary facial mimicking		at J0 and at J+15days	Yes
Secondary	Measurement of facial electromyographic activity during emotional movies viewing		Made at J0 and at J+15days	Yes
Secondary	Measurement of Empathy (Baron-Cohen), Apathy (Starkstein)		Made at J0 and at J+15days	Yes
Secondary	Measurement of the effect of Levodopa on these parameters		Made at J0 and at J+15days	Yes