Detecting Parkinson's Disease Through Speech Analysis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03133611
• Date of registration: 26/04/2017
• Prospective Registration: No
• Primary sponsor: Czech Technical University in Prague
• Public title: Detecting Parkinson's Disease Through Speech Analysis
• Scientific title: Automatic Acoustic Speech Analysis and REM Sleep Behaviour Disorder for Detecting Subjects at High Risk for Parkinson's Disease and Other Alpha-synucleinopathies
• Date of first enrolment: April 1, 2017
• Target sample size: 350
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03133611
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, Canada, Czechia, France, Germany, Italy, United States

Contacts

• Name: Jan Rusz, PhD
• Affiliation: Czech Technical University in Prague

Key inclusion & exclusion 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.



Age minimum: 50 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

REM Sleep Behavior Disorder

Intervention(s)

Other: Speech assessment

Other: Routine clinical assessment

Primary Outcome(s)

Motor Speech Disorder Examination (MSDE) [Time Frame: Within one session (15 minutes)]

Secondary Outcome(s)

SCOPA-AUT [Time Frame: Within one session (30 minutes)]

MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Time Frame: Within one session (30 minutes)]

Montreal Cognitive Assessment (MoCA) [Time Frame: Within one session (15 minutes)]

Secondary ID(s)

MJFF-2016-12546

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mayo Clinic

University Hospital, Montpellier

General University Hospital, Prague

San Raffaele University Hospital, Italy

McGill University Health Centre/Research Institute of the McGill University Health Centre

Medical University Innsbruck

Philipps University Marburg Medical Center