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Trial record 17 of 33 for:    Specific Language Impairment 1

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

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ClinicalTrials.gov Identifier: NCT02753192
Recruitment Status : Unknown
Verified April 2016 by Serge Pinto, Centre National de la Recherche Scientifique, France.
Recruitment status was:  Recruiting
First Posted : April 27, 2016
Last Update Posted : April 27, 2016
Sponsor:
Collaborator:
Instituto de Medicina Molecular João Lobo Antunes
Information provided by (Responsible Party):
Serge Pinto, Centre National de la Recherche Scientifique, France

Brief 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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Dysarthria Speech Cross-language Medical Treatment Disease Progression Other: Patients Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Dysarthria in Parkinson's Disease: Lusophony vs. Francophony Comparison
Study Start Date : January 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Global acoustic features [ Time Frame: Day of assessment ]
    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.

  2. Clinical features [ Time Frame: Day of assessment ]
    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.

  3. Patient-reported outcome measures [ Time Frame: Day of assessment ]
    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.


Secondary Outcome Measures :
  1. Prosodic analyses [ Time Frame: Day of assessment ]
    Specific analyses of language-induced prosodic variations.

  2. Intelligibility of speech [ Time Frame: Day of assessment ]
    Refined intelligibility evaluation using an auditory jury.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753192


Contacts
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Contact: Serge Pinto, Ph.D. (33)650568713 serge.pinto@lpl-aix.fr

Locations
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France
Centre Hospitalier du Pays d'Aix - Service de Neurologie Recruiting
Aix-en-Provence, France, 13100
Contact: François Viallet, M.D., Ph.D.       fviallet@ch-aix.fr   
Contact: Serge Pinto, Ph.D.    (33)6 50568713    serge.pinto@lpl-aix.fr   
Portugal
Santa Maria University Hospital Recruiting
Lisbon, Portugal
Contact: Rita Cardoso, M.Sc       ritasicardoso@gmail.com   
Contact: Joaquim J Ferreira, M.D, Ph.D.       joaquimjferreira@gmail.com   
Campu Neurologico Senior (CNS) Recruiting
Torres Vedras, Portugal
Contact: Rita Cardoso, M.Sc       ritasicardoso@gmail.com   
Contact: Joaquim J Ferreira, M.D., Ph.D.       joaquimjferreira@gmail.com   
Sponsors and Collaborators
Centre National de la Recherche Scientifique, France
Instituto de Medicina Molecular João Lobo Antunes
Investigators
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Principal Investigator: Serge Pinto, Ph.D. Laboratoire Parole et Langage, Aix-en-Provence, France
Principal Investigator: Joaquim J Ferreira, M.D, Ph.D. Instituto de Medicina Molecular, Lisobon School of Medicine, Lisbon, Portugal

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Serge Pinto, Dr. Serge Pinto, Ph.D., Centre National de la Recherche Scientifique, France
ClinicalTrials.gov Identifier: NCT02753192     History of Changes
Other Study ID Numbers: 13017
ANR-13-ISH2-0001-01 ( Other Grant/Funding Number: ANR )
FCT-ANR/NEU-SCC/0005/2013 ( Other Grant/Funding Number: FCT )
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

Additional relevant MeSH terms:
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Language Disorders
Parkinson Disease
Disease Progression
Dysarthria
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Disease Attributes
Pathologic Processes
Articulation Disorders
Speech Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms