Parkinson Disease, REM Sleep Behavior Disorder
Conditions
Keywords
Speech disorder, Acoustic analysis, Dysarthria
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.
Interventions
OTHERSpeech assessment
Each subject will undergo short non-invasive speech assessment lasting approximately 15 minutes that will be recorded using microphone.
OTHERRoutine 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.
Sponsors
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
Czech Technical University in Prague
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor Speech Disorder Examination (MSDE) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | 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. |
| SCOPA-AUT | Within one session (30 minutes) | Scale for assessment of autonomic dysfunction in Parkinson's disease. |
| Montreal Cognitive Assessment (MoCA) | Within one session (15 minutes) | Scale for assessment of several cognitive domains. |
Countries
Austria, Canada, Czechia, France, Germany, Italy, United States
Outcome results
None listed