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

NCT05807373 | Unknown

• 1 other identifier: CHUBX 2016/34
• Study Type: interventional
• Target: 60
• 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. 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.

Conditions

Parkinson Disease; Multiple System Atrophy

Keywords

Motor speech disorder; dysarthria; speech processing; Parkinson's disease; Multiple System Atrophy

Outcome Measures

Primary Outcomes (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)).

  Day 1

Secondary Outcomes (3)

• measurements of a composite acoustic index assessing speech production subsystems

  Day 1

• measurements of a composite acoustic index assessing hypokinetic, ataxic and spastic dysarthria

  Day 1

• measurements of a vocal impairment score based on perceptual assessment by an expert jury (Range 1-10)

  Day 1

Study Arms (3)

Parkinson's disease

EXPERIMENTAL

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

Procedure: voice recordings

Multiple system atrophy parkinsonian subtype (MSA-P)

EXPERIMENTAL

Diagnosis of Multiple Atrophy System (MSA-P) Parkinsonian form possible or probable according to consensus criteria (Gilman et al., 2008)

Procedure: voice recordings

Healthy volunteer

EXPERIMENTAL

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 parkinsonian subtype (MSA-P); 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:

• 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

You may not qualify if:

• Deafs and/or mutes
• Patient with speech disorders which are not related to 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)

CHU de Bordeaux - Institut des maladies neurodégénératives de Bordeaux

Bordeaux, 33000, France

RECRUITING

Centre Hospitalier Universitaire de Toulouse

Toulouse, 31000, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; Dysarthria

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wassilios MEISSNER, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Khalid DAOUDI, PhD

  nstitut National de Recherche en Informatique et en Automatique

  STUDY CHAIR

Central Study Contacts

Wassilios MEISSNER, MD, PhD

CONTACT

+335 57 82 12 53; wassilios.meissner@chu-bordeaux.fr

Sandrine VILLARS

CONTACT

+335 57 82 12 53; sandrine.villars@chu-bordeaux.fr

Study Design

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

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 11, 2023
• Study Start: March 21, 2023
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2024
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)