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

NCT ID: NCT05807373

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2024-01-02

Brief Summary

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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

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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.

Conditions

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Parkinson Disease Multiple System Atrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Parkinson's disease

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

Group Type EXPERIMENTAL

voice recordings

Intervention Type PROCEDURE

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)

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)

Group Type EXPERIMENTAL

voice recordings

Intervention Type PROCEDURE

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)

Healthy volunteer

Absence of neurologic and oto-rhino-laryngologic disease

Group Type EXPERIMENTAL

voice recordings

Intervention Type PROCEDURE

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)

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de Recherche en Informatique et en Automatique

OTHER

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wassilios MEISSNER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Khalid DAOUDI, PhD

Role: STUDY_CHAIR

nstitut National de Recherche en Informatique et en Automatique

Locations

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CHU de Bordeaux - Institut des maladies neurodégénératives de Bordeaux

Bordeaux, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Toulouse

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Wassilios MEISSNER, MD, PhD

Role: CONTACT

+335 57 82 12 53

Sandrine VILLARS

Role: CONTACT

+335 57 82 12 53

Facility Contacts

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Wassilios MEISSNER, Pr

Role: primary

+335 57 82 12 53

Sandrine VILLARS

Role: backup

335 57 82 12 53

Anne PAVY-LE-TRAON, MD,PhD

Role: primary

+335 61 77 95 19

Other Identifiers

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CHUBX 2016/34

Identifier Type: -

Identifier Source: org_study_id

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