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Enteric Nervous System in Parkinson's Disease (ENTEROPARK)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00491062
First Posted: June 25, 2007
Last Update Posted: November 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nantes University Hospital
  Purpose
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.

Condition Intervention
Parkinson's Disease Procedure: Biopsies

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Official Title: Analysis of Dopamine Neuronal Cell Loss Within the Enteric Nervous System in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Study Start Date: June 2007
Study Completion Date: November 2009
Arms Assigned Interventions
Active Comparator: Control Procedure: Biopsies
Experimental: Parkinson stade 1 Procedure: Biopsies
Experimental: Parkinson stade2 Procedure: Biopsies
Experimental: Parkinson stade 3 Procedure: Biopsies

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491062


Locations
France
CHU Nantes Gastro-enterologic and Neurologic Service
Nantes, Loire-Atlantique, France, 44000
Sponsors and Collaborators
Nantes University Hospital
Investigators
Study Director: DAMIER Philippe CHU Nantes
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00491062     History of Changes
Other Study ID Numbers: 06-5-I
First Submitted: June 22, 2007
First Posted: June 25, 2007
Last Update Posted: November 16, 2010
Last Verified: November 2010

Keywords provided by Nantes University Hospital:
Parkinson's disease
enteric nervous system

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases