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Trial record 4 of 18 for:    "Brain Diseases" AND "Multiple System Atrophy" | ( Map: France )

Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis (Voice4PD-MSA)

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ClinicalTrials.gov Identifier: NCT03577483
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : July 9, 2018
Sponsor:
Collaborator:
Institut National de Recherche en Informatique et en Automatique
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease MSA - Multiple System Atrophy Procedure: voice recordings Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Exploratory comparative multicentric study.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019


Arm Intervention/treatment
Parkinson's disease
Diagnosis of idiopathic Parkinson's disease (PD) according to criteria
Procedure: 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).

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

Healthy volunteer
Absence of neurologic and oto-rhino-laryngologic disease
Procedure: 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).




Primary Outcome Measures :
  1. Differences between groups in Dysphonia Severity Index (DSI). [ Time Frame: Day 1 ]

    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.


  2. Differences between groups in Acoustic Voice Quality Index (AVQI) [ Time Frame: Day 1 ]

    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)].


  3. Differences between groups in oral airflow (dm3/s). [ Time Frame: Day 1 ]
    This parameter will be evaluated with the EVA2 system (http://www.sqlab.fr/).

  4. Differences between groups in glottal leakage (cc/s/dB) [ Time Frame: Day 1 ]
    This parameter will be evaluated with the EVA2 system (http://www.sqlab.fr/).

  5. Differences between groups in intra-oral pressure (hPa). [ Time Frame: Day 1 ]
    This parameter will be evaluated with the EVA2 system (http://www.sqlab.fr/).


Secondary Outcome Measures :
  1. Differences between groups in perceptive analysis of dysphonia based on total GRBAS-I scale scores (range 0-18) [ Time Frame: Day 1 ]
    The GRBAS-I scale evaluates six items, i.e. G (Grade), R (Roughness), B (Breathiness), A (Asthenicity), S (Strained) and I (Instability)

  2. Differences between groups in perceptive analysis of dysarthria based on French Clinical Dysarthria Battery scores [ Time Frame: Day 1 ]
    Sum of all 12 prosody item scores and all 6 phonetic performance item scores; range 0-84.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577483


Contacts
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Contact: Wassilios MEISSNER, MD, PhD +335 57 82 12 53 wassilios.meissner@chu-bordeaux.fr
Contact: Sandrine VILLARS +335 57 82 12 53 sandrine.villars@chu-bordeaux.fr

Locations
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France
Centre Hospitalier Universitaire de Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Wassilios MEISSNER, MD, PhD    +335 57 82 12 53    wassilios.meissner@chu-bordeaux.fr   
Contact: Sandrine VILLARS    +335 57 82 12 53    sandrine.villars@chu-bordeaux.fr   
Centre Hospitalier Universitaire de Toulouse Not yet recruiting
Toulouse, France, 31000
Contact: Anne PAVY-LE-TRAON, MD,PhD    +335 61 77 95 19    pavy-letraon.a@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Institut National de Recherche en Informatique et en Automatique
Investigators
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Principal Investigator: Wassilios MEISSNER, MD,PhD University Hospital, Bordeaux
Study Chair: Khalid DAOUDI, PhD Institut National de Recherche en Informatique et en Automatique

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03577483     History of Changes
Other Study ID Numbers: CHUBX 2016/21
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Brain Diseases
Parkinson Disease
Atrophy
Parkinsonian Disorders
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases