Physiopathological Study of Autonomic Failure in Parkinson's Disease

Parkinson's Disease Clinical Trial

— SYNAPark  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748409
• Other study ID #: RC12_0264
• Status: Completed
• Phase: N/A
• First received: December 10, 2012
• Last updated: October 4, 2016
• Start date: February 2013
• Est. completion date: March 2016

Study information

• Verified date: October 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France:ANSM
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Pure Autonomic Failure

Intervention

Other:
• Biopsies of peripheral autonomic nervous system

• Autonomic dysfunction questionnaires

• Electrophysiological tests

Locations

Country	Name	City	State
France	Nantes Universitary Hospital	Nantes	Loire Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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