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Enteric Nervous System in Parkinson's Disease (ENTEROPARK)

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00491062
First received: June 22, 2007
Last updated: November 15, 2010
Last verified: November 2010
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Nantes University Hospital

Additional 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
Study First Received: June 22, 2007
Last Updated: November 15, 2010
Health Authority: France: Direction Générale de la Santé

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

ClinicalTrials.gov processed this record on May 19, 2013