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

This study is currently recruiting participants.
Verified February 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01748409
First received: December 10, 2012
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Parkinson's Disease
 Other: Biopsies of peripheral autonomic nervous system
Other: Autonomic dysfunction questionnaires
Other: Electrophysiological tests

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Physiopathological Study of Autonomic Failure in Parkinson's Disease : a Monocentric Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Evaluate association between clinical autonomic failure and neuropathological autonomic failure on biopsies. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    quality of life and of sleep will be assessed through functional tests and through questionaries.


Estimated Enrollment: 45
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Parkinson's disease
  • ages 50 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748409

Contacts
Contact: Laurene LECLAIR, PH +33 2 40 08 54 95 laurene.leclair@chu-nantes.fr

Locations
France
Nantes Universitary Hospital Recruiting
Nantes, Loire Atlantique, France, 44093
Contact: Laurene LECLAIR, PH     +33 2 40 08 54 95     laurene.leclair@chu-nantes.fr    
Principal Investigator: Laurene LECLAIR, PH            
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01748409     History of Changes
Other Study ID Numbers: RC12_0264
Study First Received: December 10, 2012
Last Updated: February 4, 2013
Health Authority: France:ANSM

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

ClinicalTrials.gov processed this record on May 23, 2013