Clinical trial NCT03133611: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
REM Sleep Behavior Disorder
Keywords: Speech disorder
Acoustic analysis
Dysarthria
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
Collaborators: name: General University Hospital, Prague
name: University Hospital, Montpellier
name: Mayo Clinic
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Medical University Innsbruck
name: San Raffaele University Hospital, Italy
name: Philipps University Marburg
First posted: 2017-04-28
Enrollment: 350
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Motor Speech Disorder Examination (MSDE)
timeFrame: Within one session (15 minutes)
Secondary outcomes:
measure: MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: Within one session (30 minutes)
measure: SCOPA-AUT
timeFrame: Within one session (30 minutes)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Within one session (15 minutes)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Prague 2
country: Czechia
facility: General University Hospital
state: CZ
city: Montpellier
country: France
facility: Gui-de-Chauliac Hospital
city: Marburg
country: Germany
facility: University of Marburg
state: Hessen
city: Milano
country: Italy
facility: San Raffaele Hospital
state: Italia
Study officials:
affiliation: Czech Technical University in Prague
name: Jan Rusz, PhD
role: STUDY_DIRECTOR
References:
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.
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.