Dysarthria in Parkinson's Disease: Lusophony vs. Francophony Comparison

Parkinson's Disease Clinical Trial

— FraLusoPark  

Official title:

Dysarthria in Parkinson's Disease: Lusophony vs. Francophony Comparison

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02753192
• Other study ID #: 13017
• Secondary ID: ANR-13-ISH2-0001
• Status: Recruiting
• Phase: N/A
• First received: April 25, 2016
• Last updated: April 25, 2016
• Start date: January 2014
• Est. completion date: July 2017

Study information

• Verified date: April 2016
• Source: Centre National de la Recherche Scientifique, France
• Contact: Serge Pinto, Ph.D.
• Phone: (33)650568713
• Email: serge.pinto[@]lpl-aix.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéPortugal: Health Ethic Committee
• Study type: Interventional

Clinical Trial Summary

Parkinson's disease (PD) affects between 1% and 2% of the world's population aged 60 and older; in Europe the prevalence is around 150 PD patients per 100,000 individuals. PD is classically characterized by a symptomatic triad that includes rest tremor, akinesia and hypertonia and although the motor expression of the symptoms involves mainly the limbs, the muscles implicated in speech production are also subject to specific dysfunctions. Motor speech disorders, so-called dysarthria, can thus be developed by PD patients. The main objective of our project is to evaluate the physiological parameters (acoustics), perceptual markers (intelligibility) and psychosocial impact of dysarthric speech in PD, in the context of language (French vs. Portuguese) modulations. Acoustic parameters are expected to be physiologically-based, linked with the motoric aspects of dysarthric speech. The same degree of impairment of such parameters should be associated with the pathology and be present universally in all patients, even if they speak different languages; that should be also the case of prosodic markers, whereas impairment of speech intelligibility may participate to the psychosocial impact in communication alteration.

PD patients will be enrolled in the study in Aix-en-Provence (N = 60) and Lisbon (N = 60). Their global motor disability will be assessed with dedicated clinical rating scales, without (off) and with (on) pharmacological treatment. Two groups of 60 healthy age-matched volunteers will provide the normal reference for between-group comparisons. Along with the off and on medication clinical examinations, several speech tasks will be recorded. Moreover, speech organ functions will also be assessed during the same examination. The psychosocial impact of dysarthria will be evaluated via self-questionnaires; it will be analysed a posteriori, as well as the speech intelligibility evaluation, and both will strengthen the overall speech assessments. This global investigation will represent a unique opportunity to provide the most precise and reliable description of PD patients' speech and its impacts on intelligibility and quality of life. Challenging and interdisciplinary aspects are combined in our project, which original cross-linguistic approach involves an international collaboration definitely new in the field of motor speech disorders.

Description:

Background - Individuals with Parkinson's disease (PD) have to deal with several aspects that contribute to voice and speech decline and thus, alteration of communication ability during the course of the disease: (i) The orofacial motor dysfunction, so-called dysarthria, which depends on the neurodegenerative processes; (ii) The effects of the medical treatment, which vary according to the disease stage; and (iii) The particular speech modifications that can be language-specific, i.e. dependent on the language spoken by the patients. The main objective of the FralusoPark project is to evaluate changes in dysarthric speech in PD as a result of medical treatment and disease duration using acoustic parameters (voice and prosody), perceptual markers (intelligibility), and patient-based outcomes (the psychosocial impact on quality of life) in two different languages (French vs. European Portuguese).

Methods - Individuals with PD will be enrolled in the study in Aix-en-Provence, France (N = 60) and Lisbon, Portugal (N = 60). Their global motor disability and orofacial motor functions will be assessed with specific clinical rating scales, without (OFF) and with (ON) medical treatment. Two groups of 60 healthy age-matched volunteers will provide the reference for between-group comparisons. Along with the clinical examinations, several speech tasks will be recorded to obtain acoustic and perceptual measures. Self-evaluation questionnaires will be used to assess the psychosocial impact of dysarthria on quality of life.

Discussion - Our three a priori hypotheses are the following: (i) Global acoustic features are altered similarly in French and Portuguese individuals with PD; (ii) Language-specific prosodic patterns might be altered differently according to the language spoken by the patients; and (iii) The impact of speech disorders on intelligibility and quality of life depends on the cultural and linguistic environment. The study combines an interdisciplinary and cross-linguistic approach to study motor speech disorders and will allow for a better understanding of the progression of speech symptoms in PD and their response to medical treatment. It will provide recommendations on how to assess speech and voice disorders in individuals with PD in order to monitor symptom progression and management.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

Inclusion Criteria:

All participants

• Age between 35 and 85 years old

• Good cooperation

• Ability to understand the information sheet

• Given signed consent

• Affiliation to a medical-social insurance regimen

• Other stable medical problems not interfering with the proposed study

Only for patients:

• Absence of any neurological, psychiatric or behavioral pathology

• Idiopathic Parkinson's disease

• Absence of medication-induced psychosis, severe depression or dementia

Exclusion Criteria:

All participants

• Illiteracy

• French/Portuguese not as native language, or bilingual participants

• Participant under tutorship or guardianship, or any other administrative or legal measure

• No cooperation or withdrawn consent

• Cognitive deficits, depression, psychosis or behavioral, neurological, medical, psychological disorders that may interfere with vital prognostic and evaluations

Only for patients:

• Non-idiopathic Parkinson's disease

• (Too) severe motor impairment impeding to participate in the study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cross-language
• Disease Progression
• Dysarthria
• Medical Treatment
• Parkinson Disease
• Parkinson's Disease
• Speech

Intervention

Other:
• Patients
Individuals with PD will be enrolled in the study in Aix-en-Provence, France (N = 60) and Lisbon, Portugal (N = 60). Their global motor disability and orofacial motor functions will be assessed with specific clinical rating scales, without (OFF) and with (ON) medical treatment. Two groups of 60 healthy age-matched volunteers will provide the reference for between-group comparisons. Along with the clinical examinations, several speech tasks will be recorded to obtain acoustic and perceptual measures. Self-evaluation questionnaires will be used to assess the psychosocial impact of dysarthria on quality of life.

Locations

Country	Name	City	State
France	Centre Hospitalier du Pays d'Aix - Service de Neurologie	Aix-en-Provence
Portugal	Santa Maria University Hospital	Lisbon
Portugal	Campu Neurologico Senior (CNS)	Torres Vedras

Sponsors (2)

Lead Sponsor	Collaborator
Centre National de la Recherche Scientifique, France	Instituto de Medicina Molecular

Countries where clinical trial is conducted

France,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global acoustic features	Participants are recorded while performing several tasks and the acoustic measures characterize dimensions of aero-phonatory control. For example, for the steady vowel /a/ phonation, two kinds of measures will be extracted: First, for a macro-analysis: fundamental frequency (F0, Hertz) and F0 variation (%); and second, for a micro-analysis: perturbation measures such as jitter factor (%), absolute shimmer (dB), and harmonics-to-noise ratio (HNR, %). For the maximal phonation time, the longest duration (in seconds) of the sustained vowel /a/ will be extracted.	Day of assessment	No
Primary	Clinical features	The neurological assessment is the Unified Parkinson's Disease Rating Scale, using the revised version provided by the Movement Disorders Society (MDS-UPDRS). The FDA2 is used to assess the functions of the speech organs, reflecting the state of the muscular effectors involved in speech production.	Day of assessment	No
Primary	Patient-reported outcome measures	Patient-reported outcome measures (PROMs), such as the Dysarthria Impact Profile (DIP), are used to obtain self-reported information about the functional impact of their speech/communication impairment. Additional self-assessments focus on the patients' perception of their quality of life (the 39-Item Parkinson's Disease Questionnaire [PDQ-39]) and on how voice/speech impairment may induce a handicap (Voice Handicap Index, VHI). The French and European Portuguese adapted DIP, VHI and PDQ-39 will be used in our study. The Patient Global Impression (PGI) scoring, and the Beck Depression Inventory (BDI) are also administered. The MDS-UPDRS also includes a patient self-assessment (sections 1.B and 2), which are administered together with the other questionnaires under medication.	Day of assessment	No
Secondary	Prosodic analyses	Specific analyses of language-induced prosodic variations.	Day of assessment	No
Secondary	Intelligibility of speech	Refined intelligibility evaluation using an auditory jury.	Day of assessment	No