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NCT Number: NCT00664157

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

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

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Key information

Conditions

IDIOPATHIC PARKINSON'S DISEASE Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU

Clermont-Ferrand, 63003, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Facial expression recognition of emotion

Behavioral

Facial expression recognition test Lexical decisiontest

Primary outcomes

  1. Facial expression recognition test

    Time frame: % of exact responses

Secondary outcomes

  1. Lexical decision test

    Time frame: The time to respond

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study 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 .

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Apr 22, 2008
Registry last updated
Jan 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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