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 has been completed.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00664157
First received: April 21, 2008
Last updated: January 18, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention
Idiopathic Parkinson's Disease
Behavioral: Facial expression recognition of emotion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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 .

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Facial expression recognition test [ Time Frame: % of exact responses ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lexical decision test [ Time Frame: The time to respond ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: September 2007
Study Completion Date: October 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2
40 patients with an idiopathic Parkinson's disease and 40 healthy paired volunteers (control group)
Behavioral: Facial expression recognition of emotion
Facial expression recognition test Lexical decisiontest
Behavioral: Facial expression recognition of emotion
Facial expression recognition test Lexical decision test

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00664157

Locations
France
CHU
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Franck Durif, PUPH University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: Pr Durif, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00664157     History of Changes
Other Study ID Numbers: CHU-0033, RBHP 2007 Durif
Study First Received: April 21, 2008
Last Updated: January 18, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Idiopathic Parkinson's disease
L-Dopa
Deep Brain stimulation
Facial expression recognition of emotion
Frequency levels
Automatic and voluntary information treatment
Patient with an Idiopathic Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014