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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Completed

CT.gov ID

NCT00664157

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Parkinson's Disease	Behavioral: Facial expression recognition of emotion Behavioral: Facial expression recognition of emotion	N/A

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

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

Study progress (healthy volunteers): Ophthalmic visit MMS Facial expression recognition test Lexical decision test

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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 Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: 2 40 patients with an idiopathic Parkinson's disease and 40 healthy paired volunteers (control group)	Behavioral: Facial expression recognition of emotion Facial expression recognition test Lexical decisiontest Behavioral: Facial expression recognition of emotion Facial expression recognition test Lexical decision test

Arm

Intervention/Treatment

Other: 2

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

Behavioral: Facial expression recognition of emotion

Facial expression recognition test Lexical decisiontest

Behavioral: Facial expression recognition of emotion

Facial expression recognition test Lexical decision test

Outcome Measures

Primary Outcome Measures

Facial expression recognition test [% of exact responses]

Secondary Outcome Measures

Lexical decision test [The time to respond]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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