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Trial record 89 of 158 for:    genetics AND Parkinson's disease

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

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ClinicalTrials.gov Identifier: NCT02627664
Recruitment Status : Completed
First Posted : December 11, 2015
Last Update Posted : May 18, 2017
Sponsor:
Collaborator:
france parkinson
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
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.

Condition or disease Intervention/treatment
Parkinson's Disease Other: observational study

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
Actual Enrollment : 70 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Study of Dysarthria, Swallowing Disorders and Respiratory in Parkinson's Disease
Actual Study Start Date : March 2011
Actual Primary Completion Date : February 9, 2017
Actual Study Completion Date : February 9, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. 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

  3. 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)

  4. Mattis scale [ Time Frame: 2 years ]
  5. LARS scale [ Time Frame: 2 years ]
  6. MADRS scale [ Time Frame: 2 years ]
  7. PAS scale [ Time Frame: 2 years ]
  8. MoCA [ Time Frame: 2 years ]
  9. 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 )



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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with Parkinson's disease (PD) with early idiopathic ( ≤ 5 years of evolution )
Criteria

Inclusion Criteria:

  • idiopathic parkinson's disease

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627664


Locations
France
Francine Niset
Lille, France, 59000
Sponsors and Collaborators
University Hospital, Lille
france parkinson
Investigators
Study Chair: luc defebvre, MD PhD CHRU LILLE FRANCE

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02627664     History of Changes
Other Study ID Numbers: 2010_21
2010-A01391-38 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Idiopathic early
Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Deglutition Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Articulation Disorders
Speech Disorders
Language Disorders
Communication Disorders
Dysarthria
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms