Clinical trial NCT05807373: Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis - Part 2
Official title: Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis - Part 2 - Voice4PD-MSA-II
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Multiple System Atrophy
Keywords: Motor speech disorder
dysarthria
speech processing
Parkinson's disease
Multiple System Atrophy
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche en Informatique et en Automatique
First posted: 2023-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Evaluation of global vocal performance score based on six acoustic components
timeFrame: Day 1
Secondary outcomes:
measure: measurements of a composite acoustic index assessing speech production subsystems
timeFrame: Day 1
measure: measurements of a composite acoustic index assessing hypokinetic, ataxic and spastic dysarthria
timeFrame: Day 1
measure: measurements of a vocal impairment score based on perceptual assessment by an expert jury (Range 1-10)
timeFrame: Day 1
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - Institut des maladies neurodégénératives de Bordeaux
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
Study officials:
affiliation: University Hospital, Bordeaux
name: Wassilios MEISSNER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: nstitut National de Recherche en Informatique et en Automatique
name: Khalid DAOUDI, PhD
role: STUDY_CHAIR
References: