Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-22 @ 12:10 PM
Study NCT ID:
NCT00664157
Status:
COMPLETED
Last Update Posted:
2011-01-19
First Post:
2008-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
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 .
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 :
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
* 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RBHP 2007 Durif | None | None | View |