Parkinson's Disease Clinical Trial
Official title:
Dysarthria in Parkinson's Disease: Lusophony vs. Francophony Comparison
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02915848 -
Long-term Stability of LFP Recorded From the STN and the Effects of DBS
|
||
Recruiting |
NCT03648905 -
Clinical Laboratory Evaluation of Chronic Autonomic Failure
|
||
Terminated |
NCT02688465 -
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).
|
Phase 4 | |
Completed |
NCT05040048 -
Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
|
||
Active, not recruiting |
NCT04006210 -
Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations
|
Phase 3 | |
Completed |
NCT02562768 -
A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease
|
Phase 1 | |
Completed |
NCT00105521 -
Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
|
Phase 3 | |
Completed |
NCT00105508 -
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
|
Phase 3 | |
Recruiting |
NCT06002581 -
Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
|
N/A | |
Completed |
NCT02236260 -
Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
|
N/A | |
Completed |
NCT00529724 -
Body Weight Gain, Parkinson, Subthalamic Stimulation
|
Phase 2 | |
Active, not recruiting |
NCT05699460 -
Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
|
||
Completed |
NCT03703570 -
A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations
|
Phase 2 | |
Completed |
NCT03462680 -
GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
|
N/A | |
Completed |
NCT02837172 -
Diagnosis of PD and PD Progression Using DWI
|
||
Not yet recruiting |
NCT04046276 -
Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease
|
N/A | |
Recruiting |
NCT02952391 -
Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol
|
N/A | |
Active, not recruiting |
NCT02937324 -
The CloudUPDRS Smartphone Software in Parkinson's Study.
|
N/A | |
Terminated |
NCT02924194 -
Deep Brain Stimulation of the nbM to Treat Mild Cognitive Impairment in Parkinson's Disease
|
N/A | |
Completed |
NCT02874274 -
Vaccination Uptake (VAX) in PD
|
N/A |