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

Idiopathic Parkinson's Disease Clinical Trial

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 .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00664157
• Other study ID #: CHU-0033
• Secondary ID: RBHP 2007 Durif
• Status: Completed
• Phase: N/A
• First received: April 21, 2008
• Last updated: January 18, 2011
• Start date: September 2007
• Est. completion date: October 2009

Study information

• Verified date: January 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Behavioral:
• Facial expression recognition of emotion
Facial expression recognition test Lexical decisiontest
• Facial expression recognition of emotion
Facial expression recognition test Lexical decision test

Locations

Country	Name	City	State
France	CHU	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facial expression recognition test		% of exact responses	Yes
Secondary	Lexical decision test		The time to respond	Yes