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
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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 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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Other: Biopsies of peripheral autonomic nervous system
Other: Autonomic dysfunction questionnaires
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 45 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
France | |
Nantes Universitary Hospital | |
Nantes, Loire Atlantique, France, 44093 |
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 |