NCT01315405

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 16, 2011

Status Verified

March 1, 2011

Enrollment Period

2.4 years

First QC Date

February 28, 2011

Last Update Submit

March 15, 2011

Conditions

Parkinson's Disease

Keywords

Emotional facial expressionApathyMirror neurons

Outcome Measures

Primary Outcomes (1)

  • Measurement of facial electromyographic activity during emotional facial expression recognition tests

    at J0 and at J+15 days

Secondary Outcomes (4)

  • Measurement of facial electromyographic activity during voluntary facial mimicking

    at J0 and at J+15days

  • Measurement of facial electromyographic activity during emotional movies viewing

    Made at J0 and at J+15days

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

    Made at J0 and at J+15days

  • Measurement of the effect of Levodopa on these parameters

    Made at J0 and at J+15days

Interventions

Emotional facial expression recognition testsBEHAVIORAL

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 Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseLethargy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ana MARQUES, PH

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 15, 2011

Study Start

July 1, 2010

Primary Completion

December 1, 2012

Study Completion

July 1, 2013

Last Updated

March 16, 2011

Record last verified: 2011-03

Locations

FR(1)