Study of Dysarthria, Swallowing Disorders and Respiratory in Parkinson's Disease (ProdDiGYPark)

May 16, 2017 updated by: University Hospital, Lille

Prospective Study of Dysarthria, Swallowing Disorders and Respiratory in Parkinson's Disease

The investigators prospectively enrolled 64 early PD patients (less than 3 years after the first symptom) in order to prospectively assess the natural history of non-dopaminergic symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients were evaluated at baseline and after 2 years in off drug condition. Clinical, psychological, neuropsychological evaluations, functional respiratory evaluation, swallowing video fluoroscopy, dysarthria, gait and axial disorders.

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59000
        • Francine Niset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Parkinson's disease (PD) with early idiopathic ( ≤ 5 years of evolution )

Description

Inclusion Criteria:

  • idiopathic parkinson's disease

Exclusion Criteria:

  • dementia
  • severe axial gait disorders
  • respiratory or ENT pathology
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
observational study
natural history of non dopaminergic signs
Other: observational study
natural history of non dopaminergic signs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dysarthria severity assessed by the BECD scale
Time Frame: 2 years
BECD (French battery of clinical evaluation of the dysarthria) is a validated scale for qualitative assessment of dysarthria severity in neurological disorders, especially PD
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
respiratory insufficiency detection
Time Frame: 2 years
pulmonary function tests include spirometry with standard spirometer and maximal inspiratory and expiratory flow volume curves . At least 3 reproductible F-V curves are necessary. Values of FCV, FEV, peak expiratory flow, peak inspiratory flow, forced expiratory flow, SNIP were measured 12 hours after last levodopa intake (off drug)
2 years
swallowing function
Time Frame: 2 years
150 mL glass of water test video fluoroscopy of swallow in off drug condition face and profile incidences: qualitative analysis of oral, pharyngeal, aspiration if necessary blindly assessed by 2 ENT experts in PD
2 years
gait axial function (freezing)
Time Frame: 2 years
SWS test rhythmic tests for differens imposed frequencies (upper lower limb and facial) kinematic analysis of gait parameters by VICON (oxford metrics)
2 years
Mattis scale
Time Frame: 2 years
2 years
LARS scale
Time Frame: 2 years
2 years
MADRS scale
Time Frame: 2 years
2 years
PAS scale
Time Frame: 2 years
2 years
MoCA
Time Frame: 2 years
2 years
Genetic Polymorphisme
Time Frame: 2 years
To evaluate of cognitive and profile correlation to the polymorphisms of COMT (catechol-O-methyltransferase: Val158Met COMT) of MAPT H1 / H2 (microtubule associated tau protein) and ApoE (Apolipoprotein-E-ε2, 3, 4 )
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

France Parkinson Association

Investigators

  • Study Chair: luc defebvre, MD PhD, CHRU LILLE FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2011

Primary Completion (Actual)

February 9, 2017

Study Completion (Actual)

February 9, 2017

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

May 18, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010_21
  • 2010-A01391-38 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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