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Enteric Nervous System in Parkinson's Disease

NCT ID: NCT00491062

Last Updated: 2010-11-16

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

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-11-30

Brief Summary

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The "core" of the neuronal lesions in Parkinson's disease (PD) is the progressive degeneration of dopamine neurons in the substantia nigra. A significant loss of dopamine neurons and the presence of Lewy bodies (a pathological hallmark in PD) in enteric neurons have also been reported in that disease. These lesions may explain the frequent gastro-intestinal dysfunction observed in PD patients. Alterations of other neuronal populations within the enteric nervous system (ENS) as well as the mechanisms responsible for these lesions (type of cell death, alteration of neuromediators gene expression) remain to be identified. The aim of the study is to demonstrate that alterations of the human ENS in PD can be evidenced by bowel biopsies and to determine whether they are correlated to the severity of motor disability and to gastrointestinal dysfunction.

Detailed Description

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Conditions

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Parkinson's Disease

Keywords

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Parkinson's disease enteric nervous system

Study Design

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Intervention Model

PARALLEL

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

Biopsies

Intervention Type PROCEDURE

Parkinson stade 1

Group Type EXPERIMENTAL

Biopsies

Intervention Type PROCEDURE

Parkinson stade2

Group Type EXPERIMENTAL

Biopsies

Intervention Type PROCEDURE

Parkinson stade 3

Group Type EXPERIMENTAL

Biopsies

Intervention Type PROCEDURE

Interventions

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Biopsies

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Parkinson's disease patients at 3 different stages:

* Early PD (before L-DOPA-induced complication);
* Patients with L-DOPA-induced complication;
* Patients with balance impairment or cognitive decline.
* Controls: patient at risk of colic cancer for whom a coloscopy is required.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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DAMIER Philippe

Role: STUDY_DIRECTOR

Nantes University Hospital

Locations

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CHU Nantes Gastro-enterologic and Neurologic Service

Nantes, Loire-Atlantique, France

Site Status

Countries

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France

References

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Lebouvier T, Neunlist M, Bruley des Varannes S, Coron E, Drouard A, N'Guyen JM, Chaumette T, Tasselli M, Paillusson S, Flamand M, Galmiche JP, Damier P, Derkinderen P. Colonic biopsies to assess the neuropathology of Parkinson's disease and its relationship with symptoms. PLoS One. 2010 Sep 14;5(9):e12728. doi: 10.1371/journal.pone.0012728.

Reference Type DERIVED
PMID: 20856865 (View on PubMed)

Other Identifiers

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06-5-I

Identifier Type: -

Identifier Source: org_study_id