Physiopathological Study of Autonomic Failure in Parkinson's Disease (SYNAPark)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified November 2014 by Nantes University Hospital
Sponsor:
Nantes University Hospital
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01748409
First received: December 10, 2012
Last updated: November 21, 2014
Last verified: November 2014
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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:
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: | July 2016 |
| Estimated Primary Completion Date: | July 2016 (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: | 45 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748409
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
| 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: | November 21, 2014 |
| Health Authority: | France:ANSM |
Keywords provided by Nantes University Hospital:
|
Autonomic failure, Parkinson's disease, electrophysiological assessment, neuropathological assessment |
Additional relevant MeSH terms:
|
Primary Dysautonomias Autonomic Nervous System Diseases Parkinson Disease Pure Autonomic Failure Parkinsonian Disorders Basal Ganglia Diseases |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on September 26, 2016