Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis (Voice4PD-MSA)
Primary Purpose
Parkinson Disease, MSA - Multiple System Atrophy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
voice recordings
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Universitaire de Bordeaux
- Centre Hospitalier Universitaire de Toulouse
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Parkinson's disease
Multiple system atrophy
Healthy volunteer
Arm Description
Diagnosis of idiopathic Parkinson's disease (PD) according to criteria
Diagnosis of Multiple Atrophy System (MSA) Parkinsonian form possible or probable according to Gilman et coll 's criteria (2008)
Absence of neurologic and oto-rhino-laryngologic disease
Outcomes
Primary Outcome Measures
Differences between groups in Dysphonia Severity Index (DSI).
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
Vowels: mean frequency (Hz), variation coefficient (%), jitter factor (%), mean intensity (dB), shimmer factor (%), and noise to harmony ratio (dB).
Speech prosody: mean frequency (Hz), variation coefficient (%), minimal frequency (Hz), maximal frequency (Hz), dynamic (Hz), mean duration of speech between two pauses (seconds), total amount of syllables (syllables/s), total amount of pure speech (syllables/s), articulation rate (syllables/s), percentage of pauses (%), percentage of pauses within words (%), time between pauses (s), SPIR index of rhythmicity (words/min), fragmentation of vowels (%), voice onset time (s), stop-consonant spirantization (%).
Aerodynamic voice parameters will be assessed with the DIANA system (http://www.sqlab.fr/) and algorithms specifically developed by GeoStat at Inria.
Differences between groups in Acoustic Voice Quality Index (AVQI)
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)].
Differences between groups in oral airflow (dm3/s).
This parameter will be evaluated with the EVA2 system (http://www.sqlab.fr/).
Differences between groups in glottal leakage (cc/s/dB)
This parameter will be evaluated with the EVA2 system (http://www.sqlab.fr/).
Differences between groups in intra-oral pressure (hPa).
This parameter will be evaluated with the EVA2 system (http://www.sqlab.fr/).
Secondary Outcome Measures
Differences between groups in perceptive analysis of dysphonia based on total GRBAS-I scale scores (range 0-18)
The GRBAS-I scale evaluates six items, i.e. G (Grade), R (Roughness), B (Breathiness), A (Asthenicity), S (Strained) and I (Instability)
Differences between groups in perceptive analysis of dysarthria based on French Clinical Dysarthria Battery scores
Sum of all 12 prosody item scores and all 6 phonetic performance item scores; range 0-84.
Full Information
NCT ID
NCT03577483
First Posted
October 20, 2017
Last Updated
November 24, 2022
Sponsor
University Hospital, Bordeaux
Collaborators
Institut National de Recherche en Informatique et en Automatique
1. Study Identification
Unique Protocol Identification Number
NCT03577483
Brief Title
Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis
Acronym
Voice4PD-MSA
Official Title
Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
June 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Institut National de Recherche en Informatique et en Automatique
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Parkinson's disease (PD) is the second most common neurodegenerative disease. Multiple system atrophy (MSA) is a relentlessly progressing rare neurodegenerative disease of unknown etiology. In early stages of the disease, PD and MSA symptoms are very similar, particularly MSA-P where Parkinsonism predominates. The differential diagnosis between MSA-P and PD can be very challenging in early disease stages, while early diagnostic certitude is important for the patient because of the diverging prognosis. Voice disorders are a common early symptom in both diseases and of different origin. The ambition and the originality of this project are to develop a digital voice-based tool for objective discrimination between PD and MSA-P.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, MSA - Multiple System Atrophy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Exploratory comparative multicentric study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parkinson's disease
Arm Type
Other
Arm Description
Diagnosis of idiopathic Parkinson's disease (PD) according to criteria
Arm Title
Multiple system atrophy
Arm Type
Other
Arm Description
Diagnosis of Multiple Atrophy System (MSA) Parkinsonian form possible or probable according to Gilman et coll 's criteria (2008)
Arm Title
Healthy volunteer
Arm Type
Other
Arm Description
Absence of neurologic and oto-rhino-laryngologic disease
Intervention Type
Procedure
Intervention Name(s)
voice recordings
Intervention Description
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).
Primary Outcome Measure Information:
Title
Differences between groups in Dysphonia Severity Index (DSI).
Description
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
Vowels: mean frequency (Hz), variation coefficient (%), jitter factor (%), mean intensity (dB), shimmer factor (%), and noise to harmony ratio (dB).
Speech prosody: mean frequency (Hz), variation coefficient (%), minimal frequency (Hz), maximal frequency (Hz), dynamic (Hz), mean duration of speech between two pauses (seconds), total amount of syllables (syllables/s), total amount of pure speech (syllables/s), articulation rate (syllables/s), percentage of pauses (%), percentage of pauses within words (%), time between pauses (s), SPIR index of rhythmicity (words/min), fragmentation of vowels (%), voice onset time (s), stop-consonant spirantization (%).
Aerodynamic voice parameters will be assessed with the DIANA system (http://www.sqlab.fr/) and algorithms specifically developed by GeoStat at Inria.
Time Frame
Day 1
Title
Differences between groups in Acoustic Voice Quality Index (AVQI)
Description
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)].
Time Frame
Day 1
Title
Differences between groups in oral airflow (dm3/s).
Description
This parameter will be evaluated with the EVA2 system (http://www.sqlab.fr/).
Time Frame
Day 1
Title
Differences between groups in glottal leakage (cc/s/dB)
Description
This parameter will be evaluated with the EVA2 system (http://www.sqlab.fr/).
Time Frame
Day 1
Title
Differences between groups in intra-oral pressure (hPa).
Description
This parameter will be evaluated with the EVA2 system (http://www.sqlab.fr/).
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Differences between groups in perceptive analysis of dysphonia based on total GRBAS-I scale scores (range 0-18)
Description
The GRBAS-I scale evaluates six items, i.e. G (Grade), R (Roughness), B (Breathiness), A (Asthenicity), S (Strained) and I (Instability)
Time Frame
Day 1
Title
Differences between groups in perceptive analysis of dysarthria based on French Clinical Dysarthria Battery scores
Description
Sum of all 12 prosody item scores and all 6 phonetic performance item scores; range 0-84.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wassilios MEISSNER, MD,PhD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Khalid DAOUDI, PhD
Organizational Affiliation
Institut National de Recherche en Informatique et en Automatique
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre Hospitalier Universitaire de Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
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Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis
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