Detecting Parkinson's Disease Through Speech Analysis

Not Applicable

• Conditions: Parkinson Disease; REM Sleep Behavior Disorder
• Interventions: Other: Speech assessment; Other: Routine clinical assessment

• Registration Number: NCT03133611
• Lead Sponsor: Czech Technical University in Prague

Brief Summary

Speech is an important indicator of motor function and movement coordination and can be extremely sensitive to involvement in the course of neurologic diseases. The aim of this project is to discover for the first time using simple speech recording and high end pattern analysis preclinical stages of disabling central nervous system disorders including Parkinson's disease and other alpha-synucleinopathies in "at high risk" patients with REM sleep behavior disorder and thus provide one essential prerequisite for trials on REM sleep behavior disorder with preventive therapy.

Detailed Description

Seven centers of excellence in sleep research will investigate speech and other clinical symptoms in more than 100 subjects with REM sleep behavior disorder. Analyses of a number of unique speech dimensions based upon three fundamental categories of simple speaking tasks will be used to search for specific prodromal alterations in speech patterns in REM sleep behavior disorder, compared to age- and gender-matched patients with early Parkinson's disease and healthy control subjects. Robust algorithms allowing automated speech analysis will be developed and optimized through English, German, French, Czech and Italian languages. Early motor dysfunction strongly predicts Parkinson's disease and other alpha-synucleinopathies. In this regard, vocal assessment has intriguing potential advances as is non-invasive, inexpensive, simple to administer and scalable to large population with possibility to perform recordings remotely, even by telephone from patients' home. Speech analysis may serve as a simple tool to screen large populations for the risk to develop Parkinson's disease. If speech impairment appears to be a strong biomarker of early motor dysfunction, the screening of speech changes may improve stratification for future neuroprotective therapies for Parkinson's disease and other synucleinopathies.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-04-28
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-09
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REM sleep behaviour disorder	Speech assessment	Speech assessment. Routine clinical assessment.
Parkinson's disease	Speech assessment	Speech assessment. Routine clinical assessment.
Parkinson's disease	Routine clinical assessment	Speech assessment. Routine clinical assessment.
Healthy controls	Speech assessment	Speech assessment. Routine clinical assessment.
Healthy controls	Routine clinical assessment	Speech assessment. Routine clinical assessment.
REM sleep behaviour disorder	Routine clinical assessment	Speech assessment. Routine clinical assessment.

Primary Outcome Measures

Name	Time	Method
Motor Speech Disorder Examination (MSDE)	Within one session (15 minutes)	Quantitative acoustic assessment of several deviant speech dimensions connected with phonatory, articulatory, and prosodic abnormalities in hypokinetic dysarthria of Parkinson's disease.

Secondary Outcome Measures

Name	Time	Method
SCOPA-AUT	Within one session (30 minutes)	Scale for assessment of autonomic dysfunction in Parkinson's disease.
MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	Within one session (30 minutes)	The most commonly used scale for the clinical evaluation of Parkinson's disease assessing variety of motor and non-motor symptoms.
Montreal Cognitive Assessment (MoCA)	Within one session (15 minutes)	Scale for assessment of several cognitive domains.

Trial Locations

Locations (7)

Medical University of Innsbruck; 🇦🇹 Innsbruck, Austria

General University Hospital; 🇨🇿 Prague 2, CZ, Czechia

Gui-de-Chauliac Hospital; 🇫🇷 Montpellier, France

University of Marburg; 🇩🇪 Marburg, Hessen, Germany

San Raffaele Hospital; 🇮🇹 Milano, Italia, Italy

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada