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Trial record 22 of 90 for:    "Brain Diseases" AND "Multiple System Atrophy"

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

Tracking Information
First Submitted Date  ICMJE October 20, 2017
First Posted Date  ICMJE July 4, 2018
Last Update Posted Date July 9, 2018
Actual Study Start Date  ICMJE June 26, 2018
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2018)
  • 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.
  • 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)].
  • 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/).
  • 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/).
  • 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/).
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
  • 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.
  • 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.
  • 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/).
  • 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/).
  • 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/).
Change History Complete list of historical versions of study NCT03577483 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis
Official Title  ICMJE Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Exploratory comparative multicentric study.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Parkinson Disease
  • MSA - Multiple System Atrophy
Intervention  ICMJE 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).
Study Arms  ICMJE
  • Parkinson's disease
    Diagnosis of idiopathic Parkinson's disease (PD) according to criteria
    Intervention: Procedure: voice recordings
  • Multiple system atrophy
    Diagnosis of Multiple Atrophy System (MSA) Parkinsonian form possible or probable according to Gilman et coll 's criteria (2008)
    Intervention: Procedure: voice recordings
  • Healthy volunteer
    Absence of neurologic and oto-rhino-laryngologic disease
    Intervention: Procedure: voice recordings
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2018)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03577483
Other Study ID Numbers  ICMJE CHUBX 2016/21
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Institut National de Recherche en Informatique et en Automatique
Investigators  ICMJE
Principal Investigator: Wassilios MEISSNER, MD,PhD University Hospital, Bordeaux
Study Chair: Khalid DAOUDI, PhD Institut National de Recherche en Informatique et en Automatique
PRS Account University Hospital, Bordeaux
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP