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Parkinson DiseaseVoice4PD-MSANCT03577483

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

A study testing voice recordings in people with Parkinson Disease and MSA - Multiple System Atrophy, run by University Hospital, Bordeaux at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 yearsHealthy volunteers can take part
What is being tested?
voice recordings
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
2 sitesFrance
Study dates
26 Jun 2018to 18 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33000

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, 31000

Other trials in France

About this study

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.

Read the 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.

Being tested
voice recordings
Medical subject headings
Parkinson Disease, Shy-Drager Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • voice recordingsProcedure or surgery

    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).

Study groups in NCT03577483
Study groupRoleWhat they receive
Parkinson's diseaseOtherDiagnosis of idiopathic Parkinson's disease (PD) according to criteria
Receives: Procedure: voice recordings
Multiple system atrophyOtherDiagnosis of Multiple Atrophy System (MSA) Parkinsonian form possible or probable according to Gilman et coll 's criteria (2008)
Receives: Procedure: voice recordings
Healthy volunteerOtherAbsence of neurologic and oto-rhino-laryngologic disease
Receives: Procedure: voice recordings

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1

  2. 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)].

    Measured: Day 1

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

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

    Measured: Day 1

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

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

    Measured: Day 1

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

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

    Measured: Day 1

Secondary outcomes (2)

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

    The GRBAS-I scale evaluates six items, i.e. G (Grade), R (Roughness), B (Breathiness), A (Asthenicity), S (Strained) and I (Instability)

    Measured: Day 1

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

    Sum of all 12 prosody item scores and all 6 phonetic performance item scores; range 0-84.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2018
  2. Study start26 Jun 2018
  3. Primary completion18 Jun 2021
  4. Study completion18 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Exploratory comparative multicentric study.
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03577483
Sponsor's protocol ID
CHUBX 2016/21
Acronym
Voice4PD-MSA
Status last verified
Nov 2022
First submitted
20 Oct 2017
Last updated
28 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing voice recordings in people with Parkinson Disease and MSA - Multiple System Atrophy, run by University Hospital, Bordeaux at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences between groups in Dysphonia Severity Index (DSI). (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03577483.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.

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