Physiopathological Study of Autonomic Failure in Parkinson's Disease (SYNAPark)

October 4, 2016 updated by: Nantes University Hospital

Physiopathological Study of Autonomic Failure in Parkinson's Disease : a Monocentric Study

The aim of the study is to evaluate the autonomic failure in Parkinson's disease by clinical, electrophysiological and neuropathological examination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Loire Atlantique
      • Nantes, Loire Atlantique, France, 44093
        • Nantes Universitary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Parkinson's disease
  • ages 45 to 80 years, both genders
  • patients who signed informed consent

Exclusion Criteria:

  • autonomic function modifying treatment
  • pre-existing neuropathy or risk factors for neuropathy
  • dementia
  • colonic disorders
  • coagulation disorders (may be due to treatment)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate association between clinical autonomic failure and neuropathological autonomic failure on biopsies.
Time Frame: 3 months

the main objective is to look after associations between :

  • anatomopathological signs of autonomic nervous system disorders seen on biopsies AND
  • clinical signs of signs of autonomic nervous system disorders seen through functional tests or through symptoms indicated by the patient on questionaries.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate association between autonomic failure and severity factors in Parkinson's disease
Time Frame: 3 months

Autonomic failure will be assessed through questionaries on symptoms and through functional tests.

Severity factors in parkinson disease will refer to various parameters like patient age.
3 months
Evaluate consequences of autonomic failure on quality of life and sleep quality
Time Frame: 3 months
quality of life and of sleep will be assessed through functional tests and through questionaries.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

December 10, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (Estimate)

December 12, 2012

Study Record Updates

Last Update Posted (Estimate)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC12_0264

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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