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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Czech Technical University in Prague

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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