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

NCT ID: NCT01142739

Last Updated: 2012-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Parkinson's Disease patient

levodopa-treated parkinson's disease (PD) patients

Clinical variables

Intervention Type OTHER

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.

Clinical variables

Intervention Type OTHER

Eye movement recordings : non-invasive infra-red camera oculometry (EyeBrain) before and after (only parkinson's disease group) levodopa(10 to 15 minute/recording)

Non Parkinson's disease controls

Non Parkinson's disease controls

Clinical variables

Intervention Type OTHER

Demography, Biological variables.

Clinical variables

Intervention Type OTHER

Eye movement recordings : non-invasive infra-red camera oculometry (EyeBrain) before and after (only parkinson's disease group) levodopa(10 to 15 minute/recording)

Interventions

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Clinical variables

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.

Intervention Type OTHER

Clinical variables

Demography, Biological variables.

Intervention Type OTHER

Clinical 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)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université Victor Segalen Bordeaux 2

OTHER

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathalie DAMON-PERRIERE, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Geneviève CHENE, Pr

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

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CHU de Bordeaux Hôpital Haut Lévêque

Pessac, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2009/20

Identifier Type: -

Identifier Source: org_study_id