NCT00664157

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

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

January 19, 2011

Status Verified

January 1, 2011

Enrollment Period

1.1 years

First QC Date

April 21, 2008

Last Update Submit

January 18, 2011

Conditions

Keywords

Idiopathic Parkinson's diseaseL-DopaDeep Brain stimulationFacial expression recognition of emotionFrequency levelsAutomatic and voluntary information treatmentPatient with an Idiopathic Parkinson's disease

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

OTHER

40 patients with an idiopathic Parkinson's disease and 40 healthy paired volunteers (control group)

Behavioral: Facial expression recognition of emotion

Interventions

Facial expression recognition test Lexical decisiontest

2

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Franck Durif, PUPH

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

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

Locations