Phosphorylation of ERK1/2 in Patients With Parkinson's Disease (BIODYS (1))
A Descriptive Study of Lymphocytic Phosphorylation of ERK1/2 in Patients With Parkinson's Disease With Dyskinesias and in Controls
Levodopa-induced dyskinesia severely limits the use of levodopa in Parkinson's disease and constitutes a debilitating complication of dopaminergic treatment in late stage. Among several neurobiological mechanisms identified so far, the investigators have established in experimental models the key role of D1 receptor hypersensitivity and a"Ras-ERK" signalling pathway. As the very same dopamine receptor machinery and the Ras-ERK pathway are present in blood lymphocytes, the investigators wish to test the hypothesis that the level of ERK phosphorylation in lymphocytes is a biomarker of levodopa-induced dyskinesia in Parkinson's Disease.
The study will be performed in dyskinetic levodopa-treated patients and non-Parkinson's Disease controls. Blood sampling "off" and "on" levodopa treatment (1 hour post-dose), as well as clinical data collection will be done during a scheduled pre-op work-up (deep brain stimulation). Subsequently, suspended lymphocytes from blood samples will be immunolabelled using an anti-pERK antibody and mean fluorescence intensity and percent of labelled lymphocytes will be assessed by flow cytometry. Additionally, plasma and urine samples will be collected "on" et "off" for dosage of dopamine. The motor effect of levodopa will be assessed through UPRSIII rating scale and eye movement (saccades) speed by non-invasive oculometric recordings.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Pessac, Francia, 33604
- CHU de Bordeaux Hopital Haut leveque
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Consecutive eligible PD in- and outpatients selected at the university hospital of Bordeaux.
- Non-demented patients (DSM IV) who are able to give their informed consent and who are affiliated to the social security.
- Controls: Subjects without known neurological disorder, non-demented, able to give their informed consent and affiliated to the social security.
Exclusion Criteria:
- Patients: Atypical or secondary parkinson disease.
- Previous or current cancer or malignant haemopathy.
- Known auto-immune disease.
- Anti-neoplastic or immuno-modulator treatment (particularly corticosteroids). Immuno-deficient subjects.
- Acute viral infection (within 2 weeks after resolving). Statin drug intake. Demented subject (DSMIV).
- Controls: Same criteria as above plus any neurological disease.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Trasversale
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Parkinson's Disease patient
levodopa-treated parkinson's disease (PD) patients
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Demography, disease duration, treatment duration, current treatment, daily intake of levodopa, Disease stage (Hoehn and Yahr, HY), motor score (UPDRS III) and dyskinesia severity (UPDRS IV).
Biological variables.
Demography, Biological variables.
Eye movement recordings : non-invasive infra-red camera oculometry (EyeBrain) before and after (only parkinson's disease group) levodopa(10 to 15 minute/recording)
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Non Parkinson's disease controls
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Demography, disease duration, treatment duration, current treatment, daily intake of levodopa, Disease stage (Hoehn and Yahr, HY), motor score (UPDRS III) and dyskinesia severity (UPDRS IV).
Biological variables.
Demography, Biological variables.
Eye movement recordings : non-invasive infra-red camera oculometry (EyeBrain) before and after (only parkinson's disease group) levodopa(10 to 15 minute/recording)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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ERK phosphorylation
Lasso di tempo: Day 1
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Distribution of variables and difference in the state of ERK phosphorylation in two contrasted groups : the dyskinetic levodopa-treated PD group and control group.
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Day 1
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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plasma and urinary dopamine in "on" and "off" state
Lasso di tempo: Day 1
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Day 1
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measure derivatives of morphine
Lasso di tempo: Day 1
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Day 1
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Nathalie DAMON-PERRIERE, Dr., University Hospital, Bordeaux
- Cattedra di studio: Geneviève CHENE, Pr, University Hospital, Bordeaux
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CHUBX 2009/20
Informazioni su farmaci e dispositivi, documenti di studio
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