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

Parkinson's Disease Clinical Trial

— ProdDiGYPark  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627664
• Other study ID #: 2010_21
• Secondary ID: 2010-A01391-38
• Status: Completed
• Phase: N/A
• First received: December 18, 2014
• Last updated: May 16, 2017
• Start date: March 2011
• Est. completion date: February 9, 2017

Study information

• Verified date: May 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 9, 2017
• Est. primary completion date: February 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• idiopathic parkinson's disease

Exclusion Criteria:

• dementia

• severe axial gait disorders

• respiratory or ENT pathology

• Pregnancy

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysarthria
• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• observational study
natural history of non dopaminergic signs

Locations

Country	Name	City	State
France	Francine Niset	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	france parkinson

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dysarthria severity assessed by the BECD scale	BECD (French battery of clinical evaluation of the dysarthria) is a validated scale for qualitative assessment of dysarthria severity in neurological disorders, especially PD	2 years
Secondary	respiratory insufficiency detection	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 years
Secondary	swallowing function	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	2 years
Secondary	gait axial function (freezing)	SWS test rhythmic tests for differens imposed frequencies (upper lower limb and facial) kinematic analysis of gait parameters by VICON (oxford metrics)	2 years
Secondary	Mattis scale		2 years
Secondary	LARS scale		2 years
Secondary	MADRS scale		2 years
Secondary	PAS scale		2 years
Secondary	MoCA		2 years
Secondary	Genetic Polymorphisme	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-e2, 3, 4 )	2 years