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Facial Expression Recognition of Emotion and Categorization of Emotional Words in Parkinson's Disease. Impact of L-Dopa and Deep Brain Stimulation of Subthalamic Nucleus
This study is currently recruiting participants.
Study NCT00664157   Information provided by University Hospital, Clermont-Ferrand
First Received: April 21, 2008   Last Updated: September 22, 2009   History of Changes

April 21, 2008
September 22, 2009
September 2007
October 2008   (final data collection date for primary outcome measure)
Facial expression recognition test [ Time Frame: % of exact responses ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00664157 on ClinicalTrials.gov Archive Site
Lexical decision test [ Time Frame: The time to respond ] [ Designated as safety issue: Yes ]
Same as current
 
Facial Expression Recognition of Emotion and Categorization of Emotional Words in Parkinson's Disease. Impact of L-Dopa and Deep Brain Stimulation of Subthalamic Nucleus
Facial Expression Recognition of Emotion and Categorization of Emotional Words in Parkinson's Disease. Impact of L-Dopa and Deep Brain Stimulation of Subthalamic Nucleus .

Parkinson'disease is a neurodegenerative disorder characterised by bradykinesia, rigidity, rest tremor and postural instability. Dopaminergic therapy such as L-Dopa and dopamine agonists usually leads to a dramatic improvement of symptoms, but disease progression nevertheless remains inevitable. Bilateral Deep brain stimulation in subthalamic nucleus is now considered the gold standard surgical treatment.

Parkinson'disease mainly affects the nigrostriatal dopaminergic system which is linked to the limbic system and could be responsible of a specific trouble in the recognition in some facial expression.

We hypothesise that patients with Parkinson'disease present a dysfunction of voluntary and automatic treatment of emotional information.

The main purpose of this study is to show if patients with Parkinson'disease present a lack of specific facial expression recognition of emotion and determinate more precisely if this alteration involves the cortical way (high frequency way) or the under cortical way (low frequency way).

We also examine the role of L-Dopa and the deep brain stimulation on emotion perception

40 patients with an Idiopathic Parkinson's disease divided in two groups :

  • 20 patients evaluated before surgery and 6 month after surgery
  • 20 patients only evaluated after surgery.

    40 paired healthy volunteers

    1) Study progress (patients):

Inclusion visit :

Neurological evaluations .

Neuropsychological evaluations : MMS, MADRS, MATTIS, BREF, Wisconsin test, Apathy test, Benton….

Ophthalmic visit : VISTECH

Protocol :

  1. for patients evaluated before surgery Facial expression recognition test Lexical decision test Made in two conditions : without the treatment (Med OFF) and one hour after the L-Dopa administration (MED ON)
  2. for patients evaluated after surgery Facial expression recognition test Lexical decision test Made in four conditions

    • Without stimulation (STIM OFF) and medication (MED OFF)
    • MED OFF and STIM ON
    • MED ON and STIM OFF
    • MED ON and STIM ON

      2) Study progress (healthy volunteers): Ophthalmic visit MMS Facial expression recognition test Lexical decision test

 
Interventional
Diagnostic, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment
Idiopathic Parkinson's Disease
Behavioral: Facial expression recognition of emotion
Other: 40 patients with an idiopathic Parkinson's disease and 40 healthy paired volunteers (control group)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
80
January 2009
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age : 30-75 years
  • Patient with an idiopathic Parkinson's disease according to the criteria of the "Parkinson's Disease Society Brain Bank" (Hughes et al., 1992)
  • Patient treated with a deep brain stimulation according to the French consensus conference of treatment of Parkinson's disease (Consensus Conference Proceeding, 2000)
  • Effect of the stimulation 50%
  • Affiliation to social security
  • Agreement of patients

Exclusion Criteria:

  • Patients suffering of an atypical Parkinson syndrome
  • Patients with severe tremor before surgery
  • Patients with a vision contrast altered.
  • Patients who do not understand the words associated with an emotion
  • Pregnant women
  • Person who participate to an other study
Both
30 Years to 75 Years
Yes
Contact: Patrick Lacarin 04.73.751.195 placarin@chu-clermontferrand.fr
France
 
NCT00664157
Pr Durif, CHU Clermont-Ferrand
CHU-0033, RBHP 2007 Durif
University Hospital, Clermont-Ferrand
 
Principal Investigator: Franck Durif, PUPH University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP