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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02627664
Acronym
ProdDiGYPark
Enrollment
70
Registered
2015-12-11
Start date
2011-03-31
Completion date
2017-02-09
Last updated
2017-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Idiopathic early, 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 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.

Interventions

OTHERobservational study

natural history of non dopaminergic signs

Sponsors

France Parkinson Association
CollaboratorOTHER
University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* idiopathic parkinson's disease

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
dysarthria severity assessed by the BECD scale2 yearsBECD (French battery of clinical evaluation of the dysarthria) is a validated scale for qualitative assessment of dysarthria severity in neurological disorders, especially PD

Secondary

MeasureTime frameDescription
swallowing function2 years150 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)2 yearsSWS test rhythmic tests for differens imposed frequencies (upper lower limb and facial) kinematic analysis of gait parameters by VICON (oxford metrics)
Mattis scale2 years
LARS scale2 years
respiratory insufficiency detection2 yearspulmonary 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)
PAS scale2 years
MoCA2 years
Genetic Polymorphisme2 yearsTo 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 )
MADRS scale2 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026