Parkinson's Disease Clinical Trial
— SYNAParkOfficial title:
Physiopathological Study of Autonomic Failure in Parkinson's Disease : a Monocentric Study
Verified date | October 2016 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | France:ANSM |
Study type | Interventional |
The aim of the study is to evaluate the autonomic failure in Parkinson's disease by clinical, electrophysiological and neuropathological examination.
Status | Completed |
Enrollment | 47 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 80 Years |
Eligibility |
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) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
France | Nantes Universitary Hospital | Nantes | Loire Atlantique |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
3 months | No |
Secondary | 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. |
3 months | No |
Secondary | 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. | 3 months | No |
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