Physiopathological Study of Autonomic Failure in Parkinson's Disease

NCT01748409 | Completed

• 1 other identifier: RC12_0264
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson's Disease

Keywords

Autonomic failure, Parkinson's disease, electrophysiological assessment, neuropathological assessment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Evaluate association between autonomic failure and severity factors in Parkinson's disease

  3 months

• Evaluate consequences of autonomic failure on quality of life and sleep quality

  3 months

Interventions

Biopsies of peripheral autonomic nervous system OTHER

Autonomic dysfunction questionnaires OTHER

Also known as: a battery of questionaries to evaluate autonomic neurological patient complaints and dysfunctions.

Electrophysiological tests OTHER

Also known as: A battery of electrophysiological tests to assess neurological functions

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Parkinson's disease
• ages 45 to 80 years, both genders
• patients who signed informed consent

You may not qualify if:

• autonomic function modifying treatment
• pre-existing neuropathy or risk factors for neuropathy
• dementia
• colonic disorders
• coagulation disorders (may be due to treatment)

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes Universitary Hospital

Nantes, Loire Atlantique, 44093, France

Location

Related Publications (1)

• Sadoc M, Clairembault T, Coron E, Berthomier C, Le Dily S, Vavasseur F, Pavageau A, St Louis EK, Pereon Y, Neunlist M, Derkinderen P, Leclair-Visonneau L. Wake and non-rapid eye movement sleep dysfunction is associated with colonic neuropathology in Parkinson's disease. Sleep. 2024 Mar 11;47(3):zsad310. doi: 10.1093/sleep/zsad310.

  PMID: 38156524 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Pure Autonomic Failure

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: February 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 5, 2016

Record last verified: 2016-10

Locations

FR (1)