Parkinson's DiseaseFraLusoParkNCT02753192
Dysarthria in Parkinson's Disease: Lusophony vs. Francophony Comparison
A study testing Patients in people with Parkinson's Disease and Dysarthria, run by Centre National de la Recherche Scientifique, France at 3 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Dysarthria, Speech
- What is being tested?
- Patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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- No cooperation or withdrawn consent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
Show all 9Show fewer
- Only for patients:
- Non-idiopathic Parkinson's disease
- (Too) severe motor impairment impeding to participate in the study
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Portugal2 sites, 2 recruiting
- Recruiting
Santa Maria University Hospital
Lisbon
Rita Cardoso, M.Sc, ritasicardoso@gmail.com
Joaquim J Ferreira, M.D, Ph.D., joaquimjferreira@gmail.com
- Recruiting
Campu Neurologico Senior (CNS)
Torres Vedras
Rita Cardoso, M.Sc, ritasicardoso@gmail.com
Joaquim J Ferreira, M.D., Ph.D., joaquimjferreira@gmail.com
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier du Pays d'Aix - Service de Neurologie
Aix-en-Provence, 13100
François Viallet, M.D., Ph.D., fviallet@ch-aix.fr
Serge Pinto, Ph.D., (33)6 50568713, serge.pinto@lpl-aix.fr
About this study
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.
Read the 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.
- Conditions
- Parkinson's Disease, Dysarthria, Speech, Cross-language, Medical Treatment, Disease Progression
- Being tested
- Patients
- Medical subject headings
- Parkinson Disease, Dysarthria, Speech, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatientsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day of assessment
Secondary outcomes (2)
Prosodic analyses
Specific analyses of language-induced prosodic variations.
Measured: Day of assessment
Intelligibility of speech
Refined intelligibility evaluation using an auditory jury.
Measured: Day of assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre National de la Recherche Scientifique, France
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Medicina Molecular João Lobo Antunes
- Responsible party
- Principal investigator, Serge Pinto, Centre National de la Recherche Scientifique, France
- Investigators
- Serge Pinto, Ph.D., Principal investigator, Laboratoire Parole et Langage, Aix-en-Provence, FranceJoaquim J Ferreira, M.D, Ph.D., Principal investigator, Instituto de Medicina Molecular, Lisobon School of Medicine, Lisbon, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753192
- Sponsor's protocol ID
- 13017
- Other IDs
- ANR-13-ISH2-0001-01, FCT-ANR/NEU-SCC/0005/2013
- Acronym
- FraLusoPark
- Status last verified
- Apr 2016
- First submitted
- 25 Apr 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Undecided
Publications
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.
PubMed 27856480
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysarthria in Parkinson's Disease: Lusophony vs. Francophony Comparison
- ClinicalTrials.gov ID
- NCT02753192
- Acronym / sponsor ID
- FraLusoPark / 13017
- Conditions
- Parkinson's Disease, Dysarthria, Speech, Cross-language, Medical Treatment, Disease Progression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre National de la Recherche Scientifique, FranceUniversity, hospital or other
- Collaborators
- Instituto de Medicina Molecular João Lobo Antunes
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Other: PatientsIndividuals 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. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All participants
- Age between 35 and 85 years old
- Good cooperation
- Ability to understand the information sheet
- Given signed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PatientsIndividuals 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. | Other | Patients |
Primary outcome
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.
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.
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.
2 secondary outcomes
Prosodic analyses
Time frame: Day of assessment
Intelligibility of speech
Time frame: Day of assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Derived from this study: PubMed 27856480Pinto 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.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serge Pinto, Ph.D. principal investigator
Laboratoire Parole et Langage, Aix-en-Provence, France
Joaquim J Ferreira, M.D, Ph.D. principal investigator
Instituto de Medicina Molecular, Lisobon School of Medicine, Lisbon, Portugal
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients in people with Parkinson's Disease and Dysarthria, run by Centre National de la Recherche Scientifique, France at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serge Pinto, Ph.D. ((33)650568713, serge.pinto@lpl-aix.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global acoustic features (time frame: Day of assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.