Enteric Nervous System in Parkinson's Disease

Parkinson's Disease Clinical Trial

— ENTEROPARK  

Official title:

Analysis of Dopamine Neuronal Cell Loss Within the Enteric Nervous System in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00491062
• Other study ID #: 06-5-I
• Status: Completed
• Phase: N/A
• First received: June 22, 2007
• Last updated: November 15, 2010
• Start date: June 2007
• Est. completion date: November 2009

Study information

• Verified date: November 2010
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Parallel Assignment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Procedure:
• Biopsies

Locations

Country	Name	City	State
France	CHU Nantes Gastro-enterologic and Neurologic Service	Nantes	Loire-Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France,