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Completed

NCT Number: NCT01748409

Physiopathological Study of Autonomic Failure in Parkinson's Disease

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

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Key information

Conditions

Parkinson's Disease Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Primary Dysautonomias Pure Autonomic Failure Synucleinopathies

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes Universitary Hospital

Nantes, Loire Atlantique, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Biopsies of peripheral autonomic nervous system

Other

Autonomic dysfunction questionnaires

Other

Other names: a battery of questionaries to evaluate autonomic neurological patient complaints and dysfunctions.

Electrophysiological tests

Other

Other names: A battery of electrophysiological tests to assess neurological functions

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: SYNAPark

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 12, 2012
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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