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Clinical Trial 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


Clinical Trial 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 ;


Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT00664157
Study type Interventional
Source University Hospital, Clermont-Ferrand
Contact
Status Completed
Phase N/A
Start date September 2007
Completion date October 2009

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