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

NCT ID: NCT03577483

Last Updated: 2022-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-26
• Study Completion Date: 2021-06-18

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. In early stages of the disease, PD and MSA symptoms are very similar, particularly MSA-P where Parkinsonism predominates. The differential diagnosis between MSA-P and PD can be very challenging in early disease stages, while early diagnostic certitude is important for the patient because of the diverging prognosis. Voice disorders are 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

Given the clinical similarity between PD and MSA-P in early disease stages and the severity of the prognosis of MSA-P, it would be very useful to have objective tools to assist in the differential diagnosis between both disorders. Since dysarthria is a common early symptom in both diseases and of different origin, the innovative goal of this project is to use dysarthria, through a digital processing of voice recordings of patients, as a vehicle to distinguish between PD and MSA-P in early disease stages.

The team will build a corpus of voice samples of patients with both diseases and a recent diagnosis (less than 4 years) and controls. This corpus will consist in sustained vowels, utterances of a standard text and spontaneous speech. The recordings will be performed using a high quality digital recorder (H4n) and the DIANA and EVA-2 workstations. DIANA is a state-of-the-art system dedicated to pathological voice recording and analysis.

An electroglottograph (EGG), a non-invasive device, will be also used in conjunction with the recordings to provide the ground truth of glottal opening and closure instants 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.

Conditions

Parkinson Disease; MSA - Multiple System Atrophy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Parkinson's disease

Diagnosis of idiopathic Parkinson's disease (PD) according to criteria

Group Type: OTHER

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

Diagnosis of Multiple Atrophy System (MSA) Parkinsonian form possible or probable according to Gilman et coll 's criteria (2008)

Group Type: OTHER

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: OTHER

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

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

Inclusion Criteria

• Patient with Parkinson's disease :

• Diagnosis of idiopathic Parkinson's disease (PD) according to criteria (Hughes et coll., 1992)
• Patient in early stage of PD : Hoehn&Yahr stage between 1 and 2, and the onset of symptoms ≤ 4 years
• Patient with or without mild to moderate speech troubles: UPDRS III item 18 ≤ 2
• Patients with MSA-P (Parkinsonian form) :

• Diagnosis of Multiple Atrophy System (MSA) Parkinsonian form possible or probable according to Gilman et coll 's criteria (2008)
• Patient in early stage of MSA-P: score of part IV of the UMSARS (Unified Multiple System Atrophy Rating Scale) ≤ 3 points and the onset of symptoms ≤ 4 years
• 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

• The deaf and/or mutes
• Patient with speech troubles which are not related to the 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

Institut National de Recherche en Informatique et en Automatique

OTHER

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wassilios MEISSNER, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Khalid DAOUDI, PhD

Role: STUDY_CHAIR

Institut National de Recherche en Informatique et en Automatique

Locations

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, , France

Centre Hospitalier Universitaire de Toulouse

Toulouse, , France

Countries

France

Other Identifiers

CHUBX 2016/21

Identifier Type: -

Identifier Source: org_study_id