Phosphorylation of ERK1/2 in Patients With Parkinson's Disease

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Clinical variables

• Registration Number: NCT01142739
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Status Verified: 2012-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-30
• Last Update Posted: 2012-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson's Disease patient	Clinical variables	levodopa-treated parkinson's disease (PD) patients
Non Parkinson's disease controls	Clinical variables	Non Parkinson's disease controls

Primary Outcome Measures

Name	Time	Method
ERK phosphorylation	Day 1	Distribution of variables and difference in the state of ERK phosphorylation in two contrasted groups : the dyskinetic levodopa-treated PD group and control group.

Secondary Outcome Measures

Name	Time	Method
measure derivatives of morphine	Day 1
plasma and urinary dopamine in "on" and "off" state	Day 1

Trial Locations

Locations (1)

CHU de Bordeaux Hôpital Haut Lévêque; 🇫🇷 Pessac, France