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Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis - Part 2 (Voice4PD-MSA)

Primary Purpose

Parkinson Disease, Multiple System Atrophy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
voice recordings
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson Disease focused on measuring Motor speech disorder, dysarthria, speech processing, Parkinson's disease, Multiple System Atrophy

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: Age from 30 to 80 years old Signed informed consent Affiliated to social security Patient with PD : Diagnosis of idiopathic Parkinson's disease (PD) according to criteria (Postuma et al., 2015) Patient PD : Hoehn&Yahr stage between 1 and 2 Patient with or without mild to moderate speech troubles: MDS-UPDRS III item 1 ≤ 2 Patients with MSA-P : Diagnosis of Multiple Atrophy System (MSA) Parkinsonian form possible or probable according to current consensus criteria (Gilman et al., 2008) Patient MSA-P: score of part IV of the UMSARS ≤ 3 points 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 : Deafs and/or mutes Patient with speech disorders which are not related to MSA or PD Person under safeguard justice, guardianship

Sites / Locations

  • CHU de Bordeaux - Institut des maladies neurodégénératives de BordeauxRecruiting
  • Centre Hospitalier Universitaire de ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Parkinson's disease

Multiple system atrophy parkinsonian subtype (MSA-P)

Healthy volunteer

Arm Description

Diagnosis of idiopathic Parkinson's disease (PD) according to MDS criteria (Postuma et al., 2015)

Diagnosis of Multiple Atrophy System (MSA-P) Parkinsonian form possible or probable according to consensus criteria (Gilman et al., 2008)

Absence of neurologic and oto-rhino-laryngologic disease

Outcomes

Primary Outcome Measures

Evaluation of global vocal performance score based on six acoustic components
1. Differences between groups (PD, MSA-P, and controls) in global vocal performance score based on six acoustic components (1. Incoordination of articulatory movements: TDV (pseudowords), 2. Difficulty initiating movements: VOT (diadochokinesis), DPI (reading text and monologue), 3. Hyperkinetic movements: stdF0, stdPSD, DVA (held vowel /a/), 4. Reduced range of motion: stdF0 (read text and monologue), 5. Slowness of movement: NSR (read text), DDKR (diadochokinesis), VD (diadochokinesis), and 6. Irregularity of movements: DDKI (diadochokinesis)).

Secondary Outcome Measures

measurements of a composite acoustic index assessing speech production subsystems
Differences between groups (PD, MSA-P, and controls) in a composite acoustic index, assessing speech production subsystems. The acoustic index will be calculated by linear combinations, described in [Daoudi et al., 2022], of features evaluating the performance of subsystems of speech production: breathing, phonation, articulation, prosody and timing.
measurements of a composite acoustic index assessing hypokinetic, ataxic and spastic dysarthria
Differences between groups (PD and MSA-P) in a composite acoustic index assessing hypokinetic, ataxic and spastic dysarthria. The acoustic index will be calculated by linear combinations, described in [Daoudi et al., 2022], of features assessing hypokinetic, ataxic and spastic dysarthria.
measurements of a vocal impairment score based on perceptual assessment by an expert jury (Range 1-10)
Differences between groups (PD and MSA-P) in a vocal impairment score based on perceptual assessment by an expert jury (Range 1-10). The score between 1 (for inaudible voice) and 10 (for normal voice) is calculated by averaging the sub-scores (between 1 and 10) evaluating intelligibility, articulation, prosody and resonance.

Full Information

First Posted
March 24, 2023
Last Updated
April 6, 2023
Sponsor
University Hospital, Bordeaux
Collaborators
Institut National de Recherche en Informatique et en Automatique
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1. Study Identification

Unique Protocol Identification Number
NCT05807373
Brief Title
Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis - Part 2
Acronym
Voice4PD-MSA
Official Title
Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis - Part 2 - Voice4PD-MSA-II
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
January 2, 2024 (Anticipated)
Study Completion Date
January 2, 2024 (Anticipated)

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
No

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. The differential diagnosis between the MSA-Parkinsonism (MSA-P) subtype and PD can be very challenging in early disease stages, while early diagnostic certitude is important for the patient because of the diverging prognosis. At the time being, there exists no validated objective biomarker to guide the clinician. Dysarthria is 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
The team will build a corpus of voice samples of patients with both diseases and healthy volunteers. This corpus will consist of sustained vowels, pseudo-words, repetition of syllables, utterances of a standard text and spontaneous speech. Voice recordings will be performed using a high quality digital recorder (H4n) and the EVA-2 workstations. EVA-2 is a state-of-the-art system dedicated to pathological voice recording and analysis, which also allows the measurement of aerodynamic features such as intra-oral and subglottal pressure. An electroglottograph (EGG), a non-invasive device, will also be used in conjunction with the recordings to provide the ground truth of glottal opening and closure instants (OGI and GCI) 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. The team will also perform a laryngostroboscopic examination to highlight defects in vocal cord mobility, a defect in vocal cord mating in phonation, abnormal vocal cord movements or supraglottic structures. The primary objective is to compare a global score assessing vocal performance between MSA-P, PD and healthy volunteers. Secondary objectives are 1) to compare an acoustic index, assessing the subsystems of speech production, between MSA-P, PD and healthy volunteers, 2) to compare an acoustic index, assessing types of dysarthria, between MSA-P and PD patients, and 3) to compare perceptual assessment, performed by a panel of experts, of voice alteration between MSA-P and PD patients. The final goal of this study is to evaluate the validity of the vocal markers that were identified in the previous study (Voice4PD-MSA-I, exploratory cohort). The validation will only consider data collected in the present study in order to assess the performance of the classifiers developed in the exploratory cohort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Multiple System Atrophy
Keywords
Motor speech disorder, dysarthria, speech processing, Parkinson's disease, Multiple System Atrophy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parkinson's disease
Arm Type
Experimental
Arm Description
Diagnosis of idiopathic Parkinson's disease (PD) according to MDS criteria (Postuma et al., 2015)
Arm Title
Multiple system atrophy parkinsonian subtype (MSA-P)
Arm Type
Experimental
Arm Description
Diagnosis of Multiple Atrophy System (MSA-P) Parkinsonian form possible or probable according to consensus criteria (Gilman et al., 2008)
Arm Title
Healthy volunteer
Arm Type
Experimental
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
Evaluation of global vocal performance score based on six acoustic components
Description
1. Differences between groups (PD, MSA-P, and controls) in global vocal performance score based on six acoustic components (1. Incoordination of articulatory movements: TDV (pseudowords), 2. Difficulty initiating movements: VOT (diadochokinesis), DPI (reading text and monologue), 3. Hyperkinetic movements: stdF0, stdPSD, DVA (held vowel /a/), 4. Reduced range of motion: stdF0 (read text and monologue), 5. Slowness of movement: NSR (read text), DDKR (diadochokinesis), VD (diadochokinesis), and 6. Irregularity of movements: DDKI (diadochokinesis)).
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
measurements of a composite acoustic index assessing speech production subsystems
Description
Differences between groups (PD, MSA-P, and controls) in a composite acoustic index, assessing speech production subsystems. The acoustic index will be calculated by linear combinations, described in [Daoudi et al., 2022], of features evaluating the performance of subsystems of speech production: breathing, phonation, articulation, prosody and timing.
Time Frame
Day 1
Title
measurements of a composite acoustic index assessing hypokinetic, ataxic and spastic dysarthria
Description
Differences between groups (PD and MSA-P) in a composite acoustic index assessing hypokinetic, ataxic and spastic dysarthria. The acoustic index will be calculated by linear combinations, described in [Daoudi et al., 2022], of features assessing hypokinetic, ataxic and spastic dysarthria.
Time Frame
Day 1
Title
measurements of a vocal impairment score based on perceptual assessment by an expert jury (Range 1-10)
Description
Differences between groups (PD and MSA-P) in a vocal impairment score based on perceptual assessment by an expert jury (Range 1-10). The score between 1 (for inaudible voice) and 10 (for normal voice) is calculated by averaging the sub-scores (between 1 and 10) evaluating intelligibility, articulation, prosody and resonance.
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: Age from 30 to 80 years old Signed informed consent Affiliated to social security Patient with PD : Diagnosis of idiopathic Parkinson's disease (PD) according to criteria (Postuma et al., 2015) Patient PD : Hoehn&Yahr stage between 1 and 2 Patient with or without mild to moderate speech troubles: MDS-UPDRS III item 1 ≤ 2 Patients with MSA-P : Diagnosis of Multiple Atrophy System (MSA) Parkinsonian form possible or probable according to current consensus criteria (Gilman et al., 2008) Patient MSA-P: score of part IV of the UMSARS ≤ 3 points 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 : Deafs and/or mutes Patient with speech disorders which are not related to MSA or PD Person under safeguard justice, guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wassilios MEISSNER, MD, PhD
Phone
+335 57 82 12 53
Email
wassilios.meissner@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sandrine VILLARS
Phone
+335 57 82 12 53
Email
sandrine.villars@chu-bordeaux.fr
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
nstitut National de Recherche en Informatique et en Automatique
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux - Institut des maladies neurodégénératives de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wassilios MEISSNER, Pr
Phone
+335 57 82 12 53
Email
wassilios.meissner@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Sandrine VILLARS
Phone
335 57 82 12 53
Email
sandrine.villars@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Wassilios MEISSNER, Pr
First Name & Middle Initial & Last Name & Degree
Alexandra Foubert-Samier, MD
Facility Name
Centre Hospitalier Universitaire de Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne PAVY-LE-TRAON, MD,PhD
Phone
+335 61 77 95 19
Email
pavy-letraon.a@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis - Part 2

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