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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Multiple System Atrophy
• Intervention / Treatment: Procedure: voice recordings

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wassilios MEISSNER, MD, PhD; Phone Number: +335 57 82 12 53; Email: wassilios.meissner@chu-bordeaux.fr
• Study Contact Backup: Name: Sandrine VILLARS; Phone Number: +335 57 82 12 53; Email: sandrine.villars@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • CHU de Bordeaux - Institut des maladies neurodégénératives de Bordeaux
    • Principal Investigator: Wassilios MEISSNER, Pr
    • Sub-Investigator: Alexandra Foubert-Samier, MD
    • Contact: Wassilios MEISSNER, Pr; Phone Number: +335 57 82 12 53; Email: wassilios.meissner@chu-bordeaux.fr
    • Contact: Sandrine VILLARS; Phone Number: 335 57 82 12 53; Email: sandrine.villars@chu-bordeaux.fr
  • Toulouse, France, 31000
    • Recruiting
    • Centre Hospitalier Universitaire de Toulouse
    • Contact: Anne PAVY-LE-TRAON, MD,PhD; Phone Number: +335 61 77 95 19; Email: pavy-letraon.a@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parkinson's disease; Diagnosis of idiopathic Parkinson's disease (PD) according to MDS criteria (Postuma et al., 2015)	Procedure: voice recordings; 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)
Experimental: Multiple system atrophy parkinsonian subtype (MSA-P); Diagnosis of Multiple Atrophy System (MSA-P) Parkinsonian form possible or probable according to consensus criteria (Gilman et al., 2008)	Procedure: voice recordings; 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)
Experimental: Healthy volunteer; Absence of neurologic and oto-rhino-laryngologic disease	Procedure: voice recordings; 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
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)).	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1
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.	Day 1
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.	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Institut National de Recherche en Informatique et en Automatique
• Investigators: Principal Investigator: Wassilios MEISSNER, MD, PhD, University Hospital, Bordeaux; Study Chair: Khalid DAOUDI, PhD, nstitut National de Recherche en Informatique et en Automatique

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Anticipated): January 2, 2024
• Study Completion (Anticipated): January 2, 2024

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Parkinson's disease; Multiple System Atrophy; dysarthria; Motor speech disorder; speech processing
• 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 2016/34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No