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

NCT ID: NCT00664157

Last Updated: 2011-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-10-31

Brief Summary

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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

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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

Conditions

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Idiopathic Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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2

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

Group Type OTHER

Facial expression recognition of emotion

Intervention Type BEHAVIORAL

Facial expression recognition test Lexical decisiontest

Facial expression recognition of emotion

Intervention Type BEHAVIORAL

Facial expression recognition test Lexical decision test

Interventions

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Facial expression recognition of emotion

Facial expression recognition test Lexical decisiontest

Intervention Type BEHAVIORAL

Facial expression recognition of emotion

Facial expression recognition test Lexical decision test

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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CHU Clermont-Ferrand

Principal Investigators

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Franck Durif, PUPH

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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RBHP 2007 Durif

Identifier Type: -

Identifier Source: secondary_id

CHU-0033

Identifier Type: -

Identifier Source: org_study_id

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