Detecting Parkinson's Disease Through Speech Analysis
Primary Purpose
Parkinson Disease, REM Sleep Behavior Disorder
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Speech assessment
Routine clinical assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson Disease focused on measuring Speech disorder, Acoustic analysis, Dysarthria
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic
- Medical University of Innsbruck
- McGill University Health Centre
- General University Hospital
- Gui-de-Chauliac Hospital
- University of Marburg
- San Raffaele Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Parkinson's disease
REM sleep behaviour disorder
Healthy controls
Arm Description
Speech assessment. Routine clinical assessment.
Speech assessment. Routine clinical assessment.
Speech assessment. Routine clinical assessment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The most commonly used scale for the clinical evaluation of Parkinson's disease assessing variety of motor and non-motor symptoms.
SCOPA-AUT
Scale for assessment of autonomic dysfunction in Parkinson's disease.
Montreal Cognitive Assessment (MoCA)
Scale for assessment of several cognitive domains.
Full Information
NCT ID
NCT03133611
First Posted
April 26, 2017
Last Updated
August 7, 2019
Sponsor
Czech Technical University in Prague
Collaborators
General University Hospital, Prague, University Hospital, Montpellier, Mayo Clinic, McGill University Health Centre/Research Institute of the McGill University Health Centre, Medical University Innsbruck, San Raffaele University Hospital, Italy, Philipps University Marburg Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03133611
Brief Title
Detecting Parkinson's Disease Through Speech Analysis
Official Title
Automatic Acoustic Speech Analysis and REM Sleep Behaviour Disorder for Detecting Subjects at High Risk for Parkinson's Disease and Other Alpha-synucleinopathies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Czech Technical University in Prague
Collaborators
General University Hospital, Prague, University Hospital, Montpellier, Mayo Clinic, McGill University Health Centre/Research Institute of the McGill University Health Centre, Medical University Innsbruck, San Raffaele University Hospital, Italy, Philipps University Marburg Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, REM Sleep Behavior Disorder
Keywords
Speech disorder, Acoustic analysis, Dysarthria
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Parkinson's disease
Arm Type
Other
Arm Description
Speech assessment. Routine clinical assessment.
Arm Title
REM sleep behaviour disorder
Arm Type
Other
Arm Description
Speech assessment. Routine clinical assessment.
Arm Title
Healthy controls
Arm Type
Other
Arm Description
Speech assessment. Routine clinical assessment.
Intervention Type
Other
Intervention Name(s)
Speech assessment
Intervention Description
Each subject will undergo short non-invasive speech assessment lasting approximately 15 minutes that will be recorded using microphone.
Intervention Type
Other
Intervention Name(s)
Routine clinical assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Motor Speech Disorder Examination (MSDE)
Description
Quantitative acoustic assessment of several deviant speech dimensions connected with phonatory, articulatory, and prosodic abnormalities in hypokinetic dysarthria of Parkinson's disease.
Time Frame
Within one session (15 minutes)
Secondary Outcome Measure Information:
Title
MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Description
The most commonly used scale for the clinical evaluation of Parkinson's disease assessing variety of motor and non-motor symptoms.
Time Frame
Within one session (30 minutes)
Title
SCOPA-AUT
Description
Scale for assessment of autonomic dysfunction in Parkinson's disease.
Time Frame
Within one session (30 minutes)
Title
Montreal Cognitive Assessment (MoCA)
Description
Scale for assessment of several cognitive domains.
Time Frame
Within one session (15 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Rusz, PhD
Organizational Affiliation
Czech Technical University in Prague
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Medical University of Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
General University Hospital
City
Prague 2
State/Province
CZ
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Gui-de-Chauliac Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
University of Marburg
City
Marburg
State/Province
Hessen
ZIP/Postal Code
D 35043
Country
Germany
Facility Name
San Raffaele Hospital
City
Milano
State/Province
Italia
ZIP/Postal Code
20127
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
26459688
Citation
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.
Results Reference
background
PubMed Identifier
22561644
Citation
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.
Results Reference
background
Links:
URL
https://foxtrialfinder.michaeljfox.org/trial/4937/
Description
Fox Trial Finder
URL
https://www.michaeljfox.org/foundation/grant-detail.php?grant_id=1616
Description
Michael J. Fox Foundation
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