Enteric Nervous System in Parkinson's Disease
ENTEROPARK
Analysis of Dopamine Neuronal Cell Loss Within the Enteric Nervous System in Parkinson's Disease
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 22, 2007
CompletedFirst Posted
Study publicly available on registry
June 25, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedNovember 16, 2010
November 1, 2010
June 22, 2007
November 15, 2010
Conditions
Keywords
Study Arms (4)
Control
ACTIVE COMPARATORParkinson stade 1
EXPERIMENTALParkinson stade2
EXPERIMENTALParkinson stade 3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Nantes Gastro-enterologic and Neurologic Service
Nantes, Loire-Atlantique, 44000, France
Related Publications (1)
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.
PMID: 20856865DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
DAMIER Philippe
Nantes University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 22, 2007
First Posted
June 25, 2007
Study Start
June 1, 2007
Study Completion
November 1, 2009
Last Updated
November 16, 2010
Record last verified: 2010-11