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

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Recruiting
CT.gov ID
NCT05807373
Collaborator
Institut National de Recherche en Informatique et en Automatique (Other)
60
2
3
9.4
30
3.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: voice recordings
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis - Part 2 - Voice4PD-MSA-II
Actual Study Start Date :
Mar 21, 2023
Anticipated Primary Completion Date :
Jan 2, 2024
Anticipated Study Completion Date :
Jan 2, 2024

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Evaluation of global vocal performance score based on six acoustic components [Day 1]

    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

  1. measurements of a composite acoustic index assessing speech production subsystems [Day 1]

    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.

  2. measurements of a composite acoustic index assessing hypokinetic, ataxic and spastic dysarthria [Day 1]

    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.

  3. measurements of a vocal impairment score based on perceptual assessment by an expert jury (Range 1-10) [Day 1]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Bordeaux - Institut des maladies neurodégénératives de Bordeaux Bordeaux France 33000
2 Centre Hospitalier Universitaire de Toulouse Toulouse France 31000

Sponsors and Collaborators

  • University Hospital, Bordeaux
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT05807373
Other Study ID Numbers:
  • CHUBX 2016/34
First Posted:
Apr 11, 2023
Last Update Posted:
Apr 11, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Bordeaux
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 11, 2023