- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Clermont-Ferrand, Frankrike, 63003
- CHU
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: 2
40 patients with an idiopathic Parkinson's disease and 40 healthy paired volunteers (control group)
|
Ansiktsuttrykksgjenkjenningstest Leksikalsk beslutningstest
Facial expression recognition test Lexical decisiontest
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Ansiktsuttrykksgjenkjenningstest
Tidsramme: % av eksakte svar
|
% av eksakte svar
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Leksikalsk beslutningstest
Tidsramme: På tide å svare
|
På tide å svare
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Franck Durif, PUPH, University Hospital, Clermont-Ferrand
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CHU-0033
- RBHP 2007 Durif
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