NCT00491062

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2007

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 16, 2010

Status Verified

November 1, 2010

First QC Date

June 22, 2007

Last Update Submit

November 15, 2010

Conditions

Keywords

Parkinson's diseaseenteric nervous system

Study Arms (4)

Control

ACTIVE COMPARATOR
Procedure: Biopsies

Parkinson stade 1

EXPERIMENTAL
Procedure: Biopsies

Parkinson stade2

EXPERIMENTAL
Procedure: Biopsies

Parkinson stade 3

EXPERIMENTAL
Procedure: Biopsies

Interventions

BiopsiesPROCEDURE
ControlParkinson stade 1Parkinson stade 3Parkinson stade2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Parkinson Disease

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • DAMIER Philippe

    Nantes University Hospital

    STUDY DIRECTOR

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

Locations