Skip to main content
OpenTrials
Completed

NCT Number: NCT02627664

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Francine Niset

Lille, 59000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • idiopathic parkinson's disease

Exclusion criteria

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

Treatment and study plan

observational study

Other

natural history of non dopaminergic signs

Primary outcomes

  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 outcomes

  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 )

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • France Parkinson Association

Registry information

Official study title

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

Acronym: ProdDiGYPark

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2015
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.