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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


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
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