- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03577483
Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis (Voice4PD-MSA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Given the clinical similarity between PD and MSA-P in early disease stages and the severity of the prognosis of MSA-P, it would be very useful to have objective tools to assist in the differential diagnosis between both disorders. Since dysarthria is a common early symptom in both diseases and of different origin, the innovative goal of this project is to use dysarthria, through a digital processing of voice recordings of patients, as a vehicle to distinguish between PD and MSA-P in early disease stages.
The team will build a corpus of voice samples of patients with both diseases and a recent diagnosis (less than 4 years) and controls. This corpus will consist in sustained vowels, utterances of a standard text and spontaneous speech. The recordings will be performed using a high quality digital recorder (H4n) and the DIANA and EVA-2 workstations. DIANA is a state-of-the-art system dedicated to pathological voice recording and analysis.
An electroglottograph (EGG), a non-invasive device, will be also used in conjunction with the recordings to provide the ground truth of glottal opening and closure instants during utterances. The use of an EGG can be very useful given that OGI and GCI provide valuable information about the voice short-time dynamics.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France, 33000
- Centre hospitalier Universitaire de Bordeaux
-
Toulouse, France, 31000
- Centre Hospitalier Universitaire de Toulouse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patient with Parkinson's disease :
- Diagnosis of idiopathic Parkinson's disease (PD) according to criteria (Hughes et coll., 1992)
- Patient in early stage of PD : Hoehn&Yahr stage between 1 and 2, and the onset of symptoms ≤ 4 years
- Patient with or without mild to moderate speech troubles: UPDRS III item 18 ≤ 2
Patients with MSA-P (Parkinsonian form) :
- Diagnosis of Multiple Atrophy System (MSA) Parkinsonian form possible or probable according to Gilman et coll 's criteria (2008)
- Patient in early stage of MSA-P: score of part IV of the UMSARS (Unified Multiple System Atrophy Rating Scale) ≤ 3 points and the onset of symptoms ≤ 4 years
- Patient with or without mild to moderate speech troubles: UMSARS II item 2 ≤ 2
Controls :
- Absence of neurologic and oto-rhino-laryngologic disease
Exclusion Criteria:
- The deaf and/or mutes
- Patient with speech troubles which are not related to the MSA or PD
- Person under safeguard justice, guardianship
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Parkinson's disease
Diagnosis of idiopathic Parkinson's disease (PD) according to criteria
|
A digital processing of voice recordings (from 30 to 45 minutes) will be performed for each participant, using a high quality digital recorder: the DIANA (computerized device of acoustic analysis) and the EVA-2 workstations (assisted Evaluation system Voice).
|
Other: Multiple system atrophy
Diagnosis of Multiple Atrophy System (MSA) Parkinsonian form possible or probable according to Gilman et coll 's criteria (2008)
|
A digital processing of voice recordings (from 30 to 45 minutes) will be performed for each participant, using a high quality digital recorder: the DIANA (computerized device of acoustic analysis) and the EVA-2 workstations (assisted Evaluation system Voice).
|
Other: Healthy volunteer
Absence of neurologic and oto-rhino-laryngologic disease
|
A digital processing of voice recordings (from 30 to 45 minutes) will be performed for each participant, using a high quality digital recorder: the DIANA (computerized device of acoustic analysis) and the EVA-2 workstations (assisted Evaluation system Voice).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences between groups in Dysphonia Severity Index (DSI).
Time Frame: Day 1
|
DSI will be calculated with the SESANE software (http://www.sqlab.fr/) and with algorithms developed by GeoStat at Inria. Evaluation of the rhythm voice
Aerodynamic voice parameters will be assessed with the DIANA system (http://www.sqlab.fr/) and algorithms specifically developed by GeoStat at Inria. |
Day 1
|
Differences between groups in Acoustic Voice Quality Index (AVQI)
Time Frame: Day 1
|
AVQI will be calculated with the SESANE software (http://www.sqlab.fr/) and with algorithms developed by GeoStat at Inria. Objective measurement of overall voice quality consisted of determining the acoustic parameters for calculating AVQI: smoothed cepstral peak prominence (CPPs) with the computer program "SpeechTool" (James Hillenbrand, Western Michigan University, Kalamazoo, MI, USA) and harmonics-to-noise ratio (HNR), shimmer local, shimmer local dB, general slope of the spectrum (slope) and tilt of the regression line through the spectrum (tilt) with Praat. Te Acoustic Voice Quality Index (AVQI) was calculated according to the regression formula: 2.571 [3.295 - 0.111 (CPPs) - 0.073 (HNR) - 0.213 (shimmer local) + 2.789 (shimmer local dB) - 0.032 (slope) + 0.077 (tilt)]. |
Day 1
|
Differences between groups in oral airflow (dm3/s).
Time Frame: Day 1
|
This parameter will be evaluated with the EVA2 system (http://www.sqlab.fr/).
|
Day 1
|
Differences between groups in glottal leakage (cc/s/dB)
Time Frame: Day 1
|
This parameter will be evaluated with the EVA2 system (http://www.sqlab.fr/).
|
Day 1
|
Differences between groups in intra-oral pressure (hPa).
Time Frame: Day 1
|
This parameter will be evaluated with the EVA2 system (http://www.sqlab.fr/).
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences between groups in perceptive analysis of dysphonia based on total GRBAS-I scale scores (range 0-18)
Time Frame: Day 1
|
The GRBAS-I scale evaluates six items, i.e.
G (Grade), R (Roughness), B (Breathiness), A (Asthenicity), S (Strained) and I (Instability)
|
Day 1
|
Differences between groups in perceptive analysis of dysarthria based on French Clinical Dysarthria Battery scores
Time Frame: Day 1
|
Sum of all 12 prosody item scores and all 6 phonetic performance item scores; range 0-84.
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wassilios MEISSNER, MD,PhD, University Hospital, Bordeaux
- Study Chair: Khalid DAOUDI, PhD, Institut National de Recherche en Informatique et en Automatique
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Pathological Conditions, Anatomical
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Hypotension
- Parkinson Disease
- Atrophy
- Multiple System Atrophy
- Shy-Drager Syndrome
Other Study ID Numbers
- CHUBX 2016/21
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on voice recordings
-
University Hospital, BordeauxInstitut National de Recherche en Informatique et en AutomatiqueRecruitingParkinson Disease | Multiple System AtrophyFrance
-
Fondazione Policlinico Universitario Agostino Gemelli...University of Florence; Campus Bio-Medico UniversityNot yet recruitingRare Diseases | Congenital DisordersItaly
-
Centre Hospitalier Universitaire de Pointe-a-PitreGroupe Hospitalier Pitie-Salpetriere; University Hospital Center of MartiniqueCompletedProgressive Supranuclear Palsy
-
Fondazione Policlinico Universitario Agostino Gemelli...Recruiting
-
Hospices Civils de LyonNot yet recruitingNormal Subject | Patient With Pharmaco-resistant EpilepsyFrance
-
University Hospital, BordeauxCompletedTourette SyndromeFrance
-
Sonova AGWestern University, Canada; Sonova Canada Inc.Recruiting
-
Manuel Sanchez LunaCompleted
-
prof. dr. Jan DeprestCompletedCesarean Section Complications | Hysterectomy | SacrocolpopexyBelgium