Detecting Parkinson's Disease Through Speech Analysis

NCT03133611 | Unknown

• 1 other identifier: MJFF-2016-12546
• Study Type: interventional
• Target: 350
• Locations: 7 countries
• Sites: 7

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.

Conditions

Parkinson Disease; REM Sleep Behavior Disorder

Keywords

Speech disorder; Acoustic analysis; Dysarthria

Outcome Measures

Primary Outcomes (1)

• Motor Speech Disorder Examination (MSDE)

  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 Outcomes (3)

• MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  Within one session (30 minutes)

• SCOPA-AUT

  Within one session (30 minutes)

• Montreal Cognitive Assessment (MoCA)

  Within one session (15 minutes)

Study Arms (3)

Parkinson's disease

OTHER

Speech assessment. Routine clinical assessment.

Other: Speech assessment; Other: Routine clinical assessment

REM sleep behaviour disorder

OTHER

Speech assessment. Routine clinical assessment.

Other: Speech assessment; Other: Routine clinical assessment

Healthy controls

OTHER

Speech assessment. Routine clinical assessment.

Other: Speech assessment; Other: Routine clinical assessment

Interventions

Speech assessment OTHER

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

Healthy controls; Parkinson's disease; REM sleep behaviour disorder

Routine clinical assessment 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; Parkinson's disease; REM sleep behaviour disorder

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Czech Technical University in Prague: lead
• General University Hospital, Prague: collaborator
• University Hospital, Montpellier: collaborator
• Mayo Clinic: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• Medical University Innsbruck: collaborator
• San Raffaele University Hospital, Italy: collaborator
• Philipps University Marburg: collaborator

Study Sites (7)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Medical University of Innsbruck

Innsbruck, 6020, Austria

Location

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

General University Hospital

Prague, CZ, 120 00, Czechia

Location

Gui-de-Chauliac Hospital

Montpellier, 34295, France

Location

University of Marburg

Marburg, Hesse, D 35043, Germany

Location

San Raffaele Hospital

Milan, Italia, 20127, Italy

Location

Related Publications (2)

• 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.

  PMID: 26459688 BACKGROUND

• 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.

  PMID: 22561644 BACKGROUND

Related Links

• Fox Trial Finder
• Michael J. Fox Foundation

MeSH Terms

Conditions

Parkinson Disease; REM Sleep Behavior Disorder; Speech Disorders; Dysarthria

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Articulation Disorders

Study Officials

• Jan Rusz, PhD

  Czech Technical University in Prague

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: April 28, 2017
• Study Start: April 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

IT (1); CA (1); US (1); CZ (1); FR (1); AU (1); DE (1)