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
2 other identifiers
interventional
80
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2007
Typical duration for not_applicable
1 active site
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
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 21, 2008
CompletedFirst Posted
Study publicly available on registry
April 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedJanuary 19, 2011
January 1, 2011
1.1 years
April 21, 2008
January 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Facial expression recognition test
% of exact responses
Secondary Outcomes (1)
Lexical decision test
The time to respond
Study Arms (1)
2
OTHER40 patients with an idiopathic Parkinson's disease and 40 healthy paired volunteers (control group)
Interventions
Facial expression recognition test Lexical decisiontest
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU
Clermont-Ferrand, 63003, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Franck Durif, PUPH
University Hospital, Clermont-Ferrand
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
April 21, 2008
First Posted
April 22, 2008
Study Start
September 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2009
Last Updated
January 19, 2011
Record last verified: 2011-01