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

NCT02753192 | Unknown

• 3 other identifiers: 13017ANR-13-ISH2-0001-01FCT-ANR/NEU-SCC/0005/2013
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (2)

• Prosodic analyses

  Day of assessment

• Intelligibility of speech

  Day of assessment

Study Arms (1)

Patients

OTHER

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

Interventions

Patients OTHER

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.

Patients

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre National de la Recherche Scientifique, France: lead
• Instituto de Medicina Molecular João Lobo Antunes: collaborator

Study Sites (3)

Centre Hospitalier du Pays d'Aix - Service de Neurologie

Aix-en-Provence, 13100, France

RECRUITING

Santa Maria University Hospital

Lisbon, Portugal

RECRUITING

Campu Neurologico Senior (CNS)

Torres Vedras, Portugal

RECRUITING

Related Publications (1)

• Pinto S, Cardoso R, Sadat J, Guimaraes I, Mercier C, Santos H, Atkinson-Clement C, Carvalho J, Welby P, Oliveira P, D'Imperio M, Frota S, Letanneux A, Vigario M, Cruz M, Martins IP, Viallet F, Ferreira JJ. Dysarthria in individuals with Parkinson's disease: a protocol for a binational, cross-sectional, case-controlled study in French and European Portuguese (FraLusoPark). BMJ Open. 2016 Nov 17;6(11):e012885. doi: 10.1136/bmjopen-2016-012885.

  PMID: 27856480 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Dysarthria; Speech; Disease Progression

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Verbal Behavior; Communication; Behavior; Disease Attributes; Pathologic Processes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serge Pinto, Ph.D.

CONTACT

(33)650568713; serge.pinto@lpl-aix.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Serge Pinto, Ph.D.

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 27, 2016
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: July 1, 2017
• Last Updated: April 27, 2016

Record last verified: 2016-04

Locations

FR (1); PT (2)