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

NCT03577483 | Completed DMC

• 1 other identifier: CHUBX 2016/21
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease; MSA - Multiple System Atrophy

Outcome Measures

Primary Outcomes (5)

• Differences between groups in Dysphonia Severity Index (DSI).

  DSI will be calculated with the SESANE software (http://www.sqlab.fr/) and with algorithms developed by GeoStat at Inria. Evaluation of the rhythm voice 1. Vowels: mean frequency (Hz), variation coefficient (%), jitter factor (%), mean intensity (dB), shimmer factor (%), and noise to harmony ratio (dB). 2. Speech prosody: mean frequency (Hz), variation coefficient (%), minimal frequency (Hz), maximal frequency (Hz), dynamic (Hz), mean duration of speech between two pauses (seconds), total amount of syllables (syllables/s), total amount of pure speech (syllables/s), articulation rate (syllables/s), percentage of pauses (%), percentage of pauses within words (%), time between pauses (s), SPIR index of rhythmicity (words/min), fragmentation of vowels (%), voice onset time (s), stop-consonant spirantization (%). Aerodynamic voice parameters will be assessed with the DIANA system (http://www.sqlab.fr/) and algorithms specifically developed by GeoStat at Inria.

  Day 1

• Differences between groups in Acoustic Voice Quality Index (AVQI)

  AVQI will be calculated with the SESANE software (http://www.sqlab.fr/) and with algorithms developed by GeoStat at Inria. Objective measurement of overall voice quality consisted of determining the acoustic parameters for calculating AVQI: smoothed cepstral peak prominence (CPPs) with the computer program "SpeechTool" (James Hillenbrand, Western Michigan University, Kalamazoo, MI, USA) and harmonics-to-noise ratio (HNR), shimmer local, shimmer local dB, general slope of the spectrum (slope) and tilt of the regression line through the spectrum (tilt) with Praat. Te Acoustic Voice Quality Index (AVQI) was calculated according to the regression formula: 2.571 \[3.295 - 0.111 (CPPs) - 0.073 (HNR) - 0.213 (shimmer local) + 2.789 (shimmer local dB) - 0.032 (slope) + 0.077 (tilt)\].

  Day 1

• Differences between groups in oral airflow (dm3/s).

  This parameter will be evaluated with the EVA2 system (http://www.sqlab.fr/).

  Day 1

• Differences between groups in glottal leakage (cc/s/dB)

  This parameter will be evaluated with the EVA2 system (http://www.sqlab.fr/).

  Day 1

• Differences between groups in intra-oral pressure (hPa).

  This parameter will be evaluated with the EVA2 system (http://www.sqlab.fr/).

  Day 1

Secondary Outcomes (2)

• Differences between groups in perceptive analysis of dysphonia based on total GRBAS-I scale scores (range 0-18)

  Day 1

• Differences between groups in perceptive analysis of dysarthria based on French Clinical Dysarthria Battery scores

  Day 1

Study Arms (3)

Parkinson's disease

OTHER

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

Procedure: voice recordings

Multiple system atrophy

OTHER

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

Procedure: voice recordings

Healthy volunteer

OTHER

Absence of neurologic and oto-rhino-laryngologic disease

Procedure: voice recordings

Interventions

voice recordings 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; Multiple system atrophy; Parkinson's disease

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The deaf and/or mutes
• Patient with speech troubles which are not related to the MSA or PD
• Person under safeguard justice, guardianship

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Institut National de Recherche en Informatique et en Automatique: collaborator

Study Sites (2)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Parkinson Disease; Shy-Drager Syndrome

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Multiple System Atrophy; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wassilios MEISSNER, MD,PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Khalid DAOUDI, PhD

  Institut National de Recherche en Informatique et en Automatique

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Exploratory comparative multicentric study.

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: July 5, 2018
• Study Start: June 26, 2018
• Primary Completion: June 18, 2021
• Study Completion: June 18, 2021
• Last Updated: November 28, 2022

Record last verified: 2022-11

Locations

FR (2)