Clinical trial NCT03577483: Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis
Official title: Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
MSA - Multiple System Atrophy
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche en Informatique et en Automatique
First posted: 2018-07-05
Enrollment: 68
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
Intervention model description: Exploratory comparative multicentric study.
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. 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.

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

Primary outcomes:
measure: Differences between groups in Dysphonia Severity Index (DSI).
timeFrame: Day 1
measure: Differences between groups in Acoustic Voice Quality Index (AVQI)
timeFrame: Day 1
measure: Differences between groups in oral airflow (dm3/s).
timeFrame: Day 1
measure: Differences between groups in glottal leakage (cc/s/dB)
timeFrame: Day 1
measure: Differences between groups in intra-oral pressure (hPa).
timeFrame: Day 1
Secondary outcomes:
measure: Differences between groups in perceptive analysis of dysphonia based on total GRBAS-I scale scores (range 0-18)
timeFrame: Day 1
measure: Differences between groups in perceptive analysis of dysarthria based on French Clinical Dysarthria Battery scores
timeFrame: Day 1
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire 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: Institut National de Recherche en Informatique et en Automatique
name: Khalid DAOUDI, PhD
role: STUDY_CHAIR
References: