Physiopathological Study of Autonomic Failure in Parkinson's Disease (SYNAPark)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biopsies of peripheral autonomic nervous system
Autonomic dysfunction questionnaires
Electrophysiological tests
Sponsored by
About this trial
This is an interventional health services research trial for Parkinson's Disease focused on measuring Autonomic failure, Parkinson's disease, electrophysiological assessment, neuropathological assessment
Eligibility Criteria
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)
Sites / Locations
- Nantes Universitary Hospital
Outcomes
Primary Outcome Measures
Evaluate association between clinical autonomic failure and neuropathological autonomic failure on biopsies.
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.
Secondary Outcome Measures
Evaluate association between autonomic failure and severity factors in Parkinson's disease
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.
Evaluate consequences of autonomic failure on quality of life and sleep quality
quality of life and of sleep will be assessed through functional tests and through questionaries.
Full Information
NCT ID
NCT01748409
First Posted
December 10, 2012
Last Updated
October 4, 2016
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01748409
Brief Title
Physiopathological Study of Autonomic Failure in Parkinson's Disease
Acronym
SYNAPark
Official Title
Physiopathological Study of Autonomic Failure in Parkinson's Disease : a Monocentric Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to evaluate the autonomic failure in Parkinson's disease by clinical, electrophysiological and neuropathological examination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Autonomic failure, Parkinson's disease, electrophysiological assessment, neuropathological assessment
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Biopsies of peripheral autonomic nervous system
Intervention Type
Other
Intervention Name(s)
Autonomic dysfunction questionnaires
Other Intervention Name(s)
a battery of questionaries to evaluate autonomic neurological patient complaints and dysfunctions.
Intervention Type
Other
Intervention Name(s)
Electrophysiological tests
Other Intervention Name(s)
A battery of electrophysiological tests to assess neurological functions
Primary Outcome Measure Information:
Title
Evaluate association between clinical autonomic failure and neuropathological autonomic failure on biopsies.
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Evaluate association between autonomic failure and severity factors in Parkinson's disease
Description
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.
Time Frame
3 months
Title
Evaluate consequences of autonomic failure on quality of life and sleep quality
Description
quality of life and of sleep will be assessed through functional tests and through questionaries.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Nantes Universitary Hospital
City
Nantes
State/Province
Loire Atlantique
ZIP/Postal Code
44093
Country
France
12. IPD Sharing Statement
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Physiopathological Study of Autonomic Failure in Parkinson's Disease
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