Physiopathological Study of Autonomic Failure in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT01748409
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-12
• Study Start: 2013-02
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluate association between clinical autonomic failure and neuropathological autonomic failure on biopsies.	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 Outcome Measures

Name	Time	Method
Evaluate association between autonomic failure and severity factors in Parkinson's disease	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	3 months	quality of life and of sleep will be assessed through functional tests and through questionaries.

Trial Locations

Locations (1)

Nantes Universitary Hospital; 🇫🇷 Nantes, Loire Atlantique, France