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

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: observational study

• Registration Number: NCT02627664
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2015-12-08
• Study First Posted: 2015-12-11
• Primary Completion: 2017-02-09
• Study Completion: 2017-02-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• idiopathic parkinson's disease

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
observational study	observational study	natural history of non dopaminergic signs

Primary Outcome Measures

Name	Time	Method
dysarthria severity assessed by the BECD scale	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

Name	Time	Method
gait axial function (freezing)	2 years	SWS test rhythmic tests for differens imposed frequencies (upper lower limb and facial) kinematic analysis of gait parameters by VICON (oxford metrics)
Genetic Polymorphisme	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 )
respiratory insufficiency detection	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	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
Mattis scale	2 years
LARS scale	2 years
MADRS scale	2 years
PAS scale	2 years
MoCA	2 years

Trial Locations

Locations (1)

Francine Niset; 🇫🇷 Lille, France