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

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ClinicalTrials.gov Identifier: NCT01748409
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Biopsies of peripheral autonomic nervous system Other: Autonomic dysfunction questionnaires Other: Electrophysiological tests Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Physiopathological Study of Autonomic Failure in Parkinson's Disease : a Monocentric Study
Study Start Date : February 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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Arms and Interventions
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Intervention Details:
    Other: Biopsies of peripheral autonomic nervous system Other: Autonomic dysfunction questionnaires
    Other Name: a battery of questionaries to evaluate autonomic neurological patient complaints and dysfunctions.
    Other: Electrophysiological tests
    Other Name: A battery of electrophysiological tests to assess neurological functions

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748409


Locations
France
Nantes Universitary Hospital
Nantes, Loire Atlantique, France, 44093
Sponsors and Collaborators
Nantes University Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01748409     History of Changes
Other Study ID Numbers: RC12_0264
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016

Keywords provided by Nantes University Hospital:
Autonomic failure, Parkinson's disease, electrophysiological assessment, neuropathological assessment

Additional relevant MeSH terms:
Parkinson Disease
Pure Autonomic Failure
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases