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 - Full Text View

Sponsor:	University Hospital, Clermont-Ferrand
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00664157

Purpose

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	Intervention
Idiopathic Parkinson's Disease	Behavioral: Facial expression recognition of emotion

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment
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 .

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

Facial expression recognition test [ Time Frame: % of exact responses ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Lexical decision test [ Time Frame: The time to respond ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	September 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

1) 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
  
  2) Study progress (healthy volunteers): Ophthalmic visit MMS Facial expression recognition test Lexical decision test

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664157

Contacts

Contact: Patrick Lacarin

04.73.751.195

placarin@chu-clermontferrand.fr

Locations

France
CHU	Recruiting
Clermont-Ferrand, France, 63003

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator:

Franck Durif, PUPH

University Hospital, Clermont-Ferrand

More Information

No publications provided

Responsible Party:	CHU Clermont-Ferrand ( Pr Durif )
Study ID Numbers:	CHU-0033, RBHP 2007 Durif
Study First Received:	April 21, 2008
Last Updated:	September 22, 2009
ClinicalTrials.gov Identifier:	NCT00664157 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

Idiopathic Parkinson's disease
L-Dopa
Deep Brain stimulation
Facial expression recognition of emotion

Frequency levels
Automatic and voluntary information treatment
Patient with an Idiopathic Parkinson's disease

Additional relevant MeSH terms:

Neurotransmitter Agents
Levodopa
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Antiparkinson Agents

Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009