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
Primary Purpose
Idiopathic Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Facial expression recognition of emotion
Facial expression recognition of emotion
Sponsored by
About this trial
This is an interventional diagnostic trial for Idiopathic Parkinson's Disease focused on measuring 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
Eligibility 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
Sites / Locations
- CHU
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
2
Arm Description
40 patients with an idiopathic Parkinson's disease and 40 healthy paired volunteers (control group)
Outcomes
Primary Outcome Measures
Facial expression recognition test
Secondary Outcome Measures
Lexical decision test
Full Information
NCT ID
NCT00664157
First Posted
April 21, 2008
Last Updated
January 18, 2011
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT00664157
Brief 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
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 .
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. Study Description
Brief Summary
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
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 :
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)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease
Keywords
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Other
Arm Description
40 patients with an idiopathic Parkinson's disease and 40 healthy paired volunteers (control group)
Intervention Type
Behavioral
Intervention Name(s)
Facial expression recognition of emotion
Intervention Description
Facial expression recognition test Lexical decisiontest
Intervention Type
Behavioral
Intervention Name(s)
Facial expression recognition of emotion
Intervention Description
Facial expression recognition test Lexical decision test
Primary Outcome Measure Information:
Title
Facial expression recognition test
Time Frame
% of exact responses
Secondary Outcome Measure Information:
Title
Lexical decision test
Time Frame
The time to respond
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck Durif, PUPH
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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