Detecting Parkinson's Disease Through Speech Analysis

NCT ID: NCT03133611

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2020-12-31

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.

Conditions

Parkinson Disease; REM Sleep Behavior Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Parkinson's disease

Speech assessment. Routine clinical assessment.

Group Type: OTHER

Speech assessment

Intervention Type: OTHER

Each subject will undergo short non-invasive speech assessment lasting approximately 15 minutes that will be recorded using microphone.

Routine clinical assessment

Intervention Type: OTHER

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.

REM sleep behaviour disorder

Speech assessment. Routine clinical assessment.

Group Type: OTHER

Speech assessment

Intervention Type: OTHER

Each subject will undergo short non-invasive speech assessment lasting approximately 15 minutes that will be recorded using microphone.

Routine clinical assessment

Intervention Type: OTHER

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.

Healthy controls

Speech assessment. Routine clinical assessment.

Group Type: OTHER

Speech assessment

Intervention Type: OTHER

Each subject will undergo short non-invasive speech assessment lasting approximately 15 minutes that will be recorded using microphone.

Routine clinical assessment

Intervention Type: OTHER

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.

Interventions

Speech assessment

Each subject will undergo short non-invasive speech assessment lasting approximately 15 minutes that will be recorded using microphone.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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;

• 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.

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

General University Hospital, Prague

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: collaborator

Medical University Innsbruck

OTHER

Sponsor Role: collaborator

San Raffaele University Hospital, Italy

OTHER

Sponsor Role: collaborator

Philipps University Marburg

OTHER

Sponsor Role: collaborator

Czech Technical University in Prague

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Rusz, PhD

Role: STUDY_DIRECTOR

Czech Technical University in Prague

Locations

Mayo Clinic

Rochester, Minnesota, United States

Medical University of Innsbruck

Innsbruck, , Austria

McGill University Health Centre

Montreal, Quebec, Canada

General University Hospital

Prague, CZ, Czechia

Gui-de-Chauliac Hospital

Montpellier, , France

University of Marburg

Marburg, Hesse, Germany

San Raffaele Hospital

Milan, Italia, Italy

Countries

United States; Austria; Canada; Czechia; France; Germany; Italy

References

Rusz J, Hlavnicka J, Tykalova T, Buskova J, Ulmanova O, Ruzicka E, Sonka K. Quantitative assessment of motor speech abnormalities in idiopathic rapid eye movement sleep behaviour disorder. Sleep Med. 2016 Mar;19:141-7. doi: 10.1016/j.sleep.2015.07.030. Epub 2015 Sep 14.

Reference Type: BACKGROUND

PMID: 26459688 (View on PubMed)

Postuma RB, Lang AE, Gagnon JF, Pelletier A, Montplaisir JY. How does parkinsonism start? Prodromal parkinsonism motor changes in idiopathic REM sleep behaviour disorder. Brain. 2012 Jun;135(Pt 6):1860-70. doi: 10.1093/brain/aws093. Epub 2012 May 4.

Reference Type: BACKGROUND

PMID: 22561644 (View on PubMed)

Related Links

https://foxtrialfinder.michaeljfox.org/trial/4937/

Fox Trial Finder

https://www.michaeljfox.org/foundation/grant-detail.php?grant_id=1616

Michael J. Fox Foundation

Other Identifiers

MJFF-2016-12546

Identifier Type: -

Identifier Source: org_study_id