Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis - Part 2 - Voice4PD-MSA-II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Evaluation of global vocal performance score based on six acoustic components
研究概览
简要总结
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.
详细描述
The team will build a corpus of voice samples of patients with both diseases and healthy volunteers. This corpus will consist of sustained vowels, pseudo-words, repetition of syllables, utterances of a standard text and spontaneous speech. Voice recordings will be performed using a high quality digital recorder (H4n) and the EVA-2 workstations. EVA-2 is a state-of-the-art system dedicated to pathological voice recording and analysis, which also allows the measurement of aerodynamic features such as intra-oral and subglottal pressure.
An electroglottograph (EGG), a non-invasive device, will also be used in conjunction with the recordings to provide the ground truth of glottal opening and closure instants (OGI and GCI) 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.
The team will also perform a laryngostroboscopic examination to highlight defects in vocal cord mobility, a defect in vocal cord mating in phonation, abnormal vocal cord movements or supraglottic structures.
The primary objective is to compare a global score assessing vocal performance between MSA-P, PD and healthy volunteers. Secondary objectives are 1) to compare an acoustic index, assessing the subsystems of speech production, between MSA-P, PD and healthy volunteers, 2) to compare an acoustic index, assessing types of dysarthria, between MSA-P and PD patients, and 3) to compare perceptual assessment, performed by a panel of experts, of voice alteration between MSA-P and PD patients.
The final goal of this study is to evaluate the validity of the vocal markers that were identified in the previous study (Voice4PD-MSA-I, exploratory cohort). The validation will only consider data collected in the present study in order to assess the performance of the classifiers developed in the exploratory cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria:
- •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
排除标准
- •Deafs and/or mutes
- •Patient with speech disorders which are not related to MSA or PD
- •Person under safeguard justice, guardianship
研究组 & 干预措施
Multiple system atrophy parkinsonian subtype (MSA-P)
Diagnosis of Multiple Atrophy System (MSA-P) Parkinsonian form possible or probable according to consensus criteria (Gilman et al., 2008)
干预措施: voice recordings (Procedure)
Healthy volunteer
Absence of neurologic and oto-rhino-laryngologic disease
干预措施: voice recordings (Procedure)
Parkinson's disease
Diagnosis of idiopathic Parkinson's disease (PD) according to MDS criteria (Postuma et al., 2015)
干预措施: voice recordings (Procedure)
结局指标
主要结局
Evaluation of global vocal performance score based on six acoustic components
时间窗: Day 1
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)).
次要结局
- 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)