Clinical Trial: Study of Dysarthria, Swallowing Disorders and Respiratory in Parkinson's Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary: 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.
Sponsor: University Hospital, Lille

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)
  • 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
  • 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)
  • Mattis scale [ Time Frame: 2 years ]
  • LARS scale [ Time Frame: 2 years ]
  • MADRS scale [ Time Frame: 2 years ]
  • PAS scale [ Time Frame: 2 years ]
  • MoCA [ Time Frame: 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 )


Original Secondary Outcome:

  • 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)
  • 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
  • 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)
  • Mattis scale [ Time Frame: 2 years ]
  • LARS scale [ Time Frame: 2 years ]
  • MADRS scale [ Time Frame: 2 years ]
  • PAS scale [ Time Frame: 2 years ]
  • MoCA [ Time Frame: 2 years ]


Information By: University Hospital, Lille

Dates:
Date Received: December 18, 2014
Date Started: March 2011
Date Completion:
Last Updated: May 16, 2017
Last Verified: May 2017