Detecting Parkinson's Disease Through Speech Analysis

August 7, 2019 updated by: Czech Technical University in Prague

Automatic Acoustic Speech Analysis and REM Sleep Behaviour Disorder for Detecting Subjects at High Risk for Parkinson's Disease and Other Alpha-synucleinopathies

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Medical University of Innsbruck
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Centre
  • Czechia
    • CZ
      • Prague 2, CZ, Czechia, 120 00
        • General University Hospital
  • France
      • Montpellier, France, 34295
        • Gui-de-Chauliac Hospital
  • Germany
    • Hessen
      • Marburg, Hessen, Germany, D 35043
        • University of Marburg
  • Italy
    • Italia
      • Milano, Italia, Italy, 20127
        • San Raffaele Hospital
  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria for subjects with Parkinson's disease (PD):

  • Diagnosed based on the MDS Clinical Diagnostic Criteria for Parkinson's Disease including the presence of bradykinesia in combination with either rest tremor, rigidity, or both;
  • Hoehn & Yahr stage 1-2 in the defined OFF state;
  • Disease duration from diagnosis < 5 years;
  • No motor fluctuations or dyskinesias;
  • On stable dose of medication in last four weeks;
  • Onset of PD after 50 years;
  • No history of communication or neurological disorders unrelated to PD;
  • Not currently involved in any speech therapy;

Inclusion Criteria for subjects with REM Sleep Behaviour Disorder (RBD):

  • Fulfill criteria for RBD based on polysomnography according to the standard International Classification of Sleep Disorders diagnostic criteria, 3rd edition;
  • Onset of RBD after 50 years;
  • No history of communication or neurological disorders.

Inclusion Criteria for healthy control subjects:

  • No history of communication or neurological disorders, parasomnias and other sleep disorders with important severity;
  • No regular benzodiazepines, hypnotics and melatonin intake.

Exclusion criteria:

(for all the arms) Inability to speak and read a text aloud.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Parkinson's disease
Speech assessment. Routine clinical assessment.
Other: Speech assessment
Each subject will undergo short non-invasive speech assessment lasting approximately 15 minutes that will be recorded using microphone.
Other: Routine clinical assessment
Volunteers who enroll in the study will undergo various assessments lasting about 2 hours, including neurological examination of both motor and non-motor skills, autonomic testing and cognitive testing.
Other: REM sleep behaviour disorder
Speech assessment. Routine clinical assessment.
Other: Speech assessment
Each subject will undergo short non-invasive speech assessment lasting approximately 15 minutes that will be recorded using microphone.
Other: Routine clinical assessment
Volunteers who enroll in the study will undergo various assessments lasting about 2 hours, including neurological examination of both motor and non-motor skills, autonomic testing and cognitive testing.
Other: Healthy controls
Speech assessment. Routine clinical assessment.
Other: Speech assessment
Each subject will undergo short non-invasive speech assessment lasting approximately 15 minutes that will be recorded using microphone.
Other: Routine clinical assessment
Volunteers who enroll in the study will undergo various assessments lasting about 2 hours, including neurological examination of both motor and non-motor skills, autonomic testing and cognitive testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor Speech Disorder Examination (MSDE)
Time Frame: 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.
Within one session (15 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time Frame: 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.
Within one session (30 minutes)
SCOPA-AUT
Time Frame: Within one session (30 minutes)
Scale for assessment of autonomic dysfunction in Parkinson's disease.
Within one session (30 minutes)
Montreal Cognitive Assessment (MoCA)
Time Frame: Within one session (15 minutes)
Scale for assessment of several cognitive domains.
Within one session (15 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Czech Technical University in Prague

Collaborators

Mayo Clinic
University Hospital, Montpellier
McGill University Health Centre/Research Institute of the McGill University Health Centre
Medical University Innsbruck
Philipps University Marburg Medical Center
General University Hospital, Prague
San Raffaele University Hospital, Italy

Investigators

  • Study Director: Jan Rusz, PhD, Czech Technical University in Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MJFF-2016-12546

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified clinical data (speech recordings and associated clinical scales) may be shared with the Michael J. Fox Foundation (the study funder). This data may be kept for storage at a central repository either hosted by the Michael J. Fox Foundation, its collaborators, or consultants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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