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Parkinson DiseaseVoice4PD-MSANCT05807373

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

A study testing voice recordings in people with Parkinson Disease and Multiple System Atrophy, run by University Hospital, Bordeaux at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Parkinson Disease, Multiple System Atrophy
What is being tested?
voice recordings
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesFrance
Study dates
21 Mar 2023to 3 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • Deafs and/or mutes
  • Patient with speech disorders which are not related to MSA or PD
  • Person under safeguard justice, guardianship

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHU de Bordeaux - Institut des maladies neurodégénératives de Bordeaux

    Bordeaux, 33000

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, 31000

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
voice recordings
Keywords
Motor speech disorder, dysarthria, speech processing, Parkinson's disease, Multiple System Atrophy
Medical subject headings
Parkinson Disease, Multiple System Atrophy, Dysarthria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • voice recordingsProcedure or surgery

    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)

Study groups in NCT05807373
Study groupRoleWhat they receive
Parkinson's diseaseExperimentalDiagnosis of idiopathic Parkinson's disease (PD) according to MDS criteria (Postuma et al., 2015)
Receives: Procedure: voice recordings
Multiple system atrophy parkinsonian subtype (MSA-P)ExperimentalDiagnosis of Multiple Atrophy System (MSA-P) Parkinsonian form possible or probable according to consensus criteria (Gilman et al., 2008)
Receives: Procedure: voice recordings
Healthy volunteerExperimentalAbsence of neurologic and oto-rhino-laryngologic disease
Receives: Procedure: voice recordings

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)).

    Measured: Day 1

Secondary outcomes (3)

  1. 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.

    Measured: Day 1

  2. 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.

    Measured: Day 1

  3. 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.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2023
  2. Study start21 Mar 2023
  3. Primary completion3 Sep 2024
  4. Study completion3 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05807373
Sponsor's protocol ID
CHUBX 2016/34
Other IDs
2022-A01998-35
Acronym
Voice4PD-MSA
Status last verified
Apr 2023
First submitted
24 Mar 2023
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Daoudi K, Yahaya F, de Saint Victor SM, Foubert-Samier A, Fabbri M, Pavy-Le Traon A, Rascol O, Devoucoux C, Woisard V, Meissner WG. Speech glottal flow performance in early stages of Parkinson's disease and multiple systems atrophy. J Commun Disord. 2026 Sep 12;124:106696. doi: 10.1016/j.jcomdis.2026.106696. Online ahead of print.

    PubMed 42735526

Questions about this trial

What is this clinical trial studying?

A study testing voice recordings in people with Parkinson Disease and Multiple System Atrophy, run by University Hospital, Bordeaux at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of global vocal performance score based on six acoustic components (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05807373, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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