Parkinson DiseaseNCT03133611
Detecting Parkinson's Disease Through Speech Analysis
A study testing Speech assessment and Routine clinical assessment in people with Parkinson Disease and REM Sleep Behavior Disorder, run by Czech Technical University in Prague at 7 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, REM Sleep Behavior Disorder
- What is being tested?
- Speech assessment and Routine clinical assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 1 Apr 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No history of communication or neurological disorders, parasomnias and other sleep disorders with important severity;
- No regular benzodiazepines, hypnotics and melatonin intake.
Who cannot join
- (for all the arms) Inability to speak and read a text aloud.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
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
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.
Read the 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
- Being tested
- Speech assessment, Routine clinical assessment
- Keywords
- Speech disorder, Acoustic analysis, Dysarthria
- Medical subject headings
- Parkinson Disease, REM Sleep Behavior Disorder, Speech Disorders, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech assessmentOther
Each subject will undergo short non-invasive speech assessment lasting approximately 15 minutes that will be recorded using microphone.
Routine clinical assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease | Other | Speech assessment. Routine clinical assessment. Receives: Other: Speech assessment; Other: Routine clinical assessment |
| REM sleep behaviour disorder | Other | Speech assessment. Routine clinical assessment. Receives: Other: Speech assessment; Other: Routine clinical assessment |
| Healthy controls | Other | Speech assessment. Routine clinical assessment. Receives: Other: Speech assessment; Other: Routine clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within one session (15 minutes)
Secondary outcomes (3)
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.
Measured: Within one session (30 minutes)
SCOPA-AUT
Scale for assessment of autonomic dysfunction in Parkinson's disease.
Measured: Within one session (30 minutes)
Montreal Cognitive Assessment (MoCA)
Scale for assessment of several cognitive domains.
Measured: Within one session (15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Apr 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Jan Rusz, PhD, Study director, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133611
- Sponsor's protocol ID
- MJFF-2016-12546
- Status last verified
- Aug 2019
- First submitted
- 26 Apr 2017
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 26459688Postuma 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.
PubMed 22561644
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03133611
- Acronym / sponsor ID
- MJFF-2016-12546
- Conditions
- Parkinson Disease, REM Sleep Behavior Disorder
- Keywords
- Speech disorder, Acoustic analysis, Dysarthria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- 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
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | Other | Other: Speech assessment, Other: Routine clinical assessmentSpeech assessment. Routine clinical assessment. |
| REM sleep behaviour disorder | Other | Other: Speech assessment, Other: Routine clinical assessmentSpeech assessment. Routine clinical assessment. |
| Healthy controls | Other | Other: Speech assessment, Other: Routine clinical assessmentSpeech assessment. Routine clinical assessment. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- No history of communication or neurological disorders, parasomnias and other sleep disorders with important severity;
- No regular benzodiazepines, hypnotics and melatonin intake.
Key exclusion criteria (1 listed)
- (for all the arms) Inability to speak and read a text aloud.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech assessmentEach subject will undergo short non-invasive speech assessment lasting approximately 15 minutes that will be recorded using microphone. | Other | Healthy controls, Parkinson's disease, REM sleep behaviour disorder |
| Routine clinical assessmentVolunteers 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, Parkinson's disease, REM sleep behaviour disorder |
Primary outcome
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.
3 secondary outcomes
MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Within one session (30 minutes)
SCOPA-AUT
Time frame: Within one session (30 minutes)
Montreal Cognitive Assessment (MoCA)
Time frame: Within one session (15 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Background: PubMed 26459688Rusz 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.
- Background: PubMed 22561644Postuma 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.
- Fox Trial FinderLink provided by the sponsor.
- Michael J. Fox FoundationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Rusz, PhD study director
Czech Technical University in Prague
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech assessment and Routine clinical assessment in people with Parkinson Disease and REM Sleep Behavior Disorder, run by Czech Technical University in Prague at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Austria, Canada, Czechia, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Speech Disorder Examination (MSDE) (time frame: Within one session (15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03133611, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.