SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dopaminergic OFF drug state, DBS OFF state, Dopaminergic ON drug state, DBS ON state.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: 30 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
With this study, the investigators want to investigate whether computerized speech analysis can be used to reliably and objectively detect motor, emotional, and cognitive fluctuations in Parkinson's disease patients.
Detailed description
Parkinson's disease (PD) affects mobility (motor function), thought processes (cognition) and mood (emotion). The language is one of the most complex programs in humans. It contains information about mobility, thinking and mood at the same time. These three levels of agility, thinking and mood are subject to spontaneous fluctuations and can be influenced by external stimuli such as pictures that induce emotions. In addition, these three levels are influenced on the one hand by Parkinson's disease itself, and on the other hand by its treatment with medication or with deep brain stimulation (DBS). For this reason, the investigators would like to investigate language in Parkinson's disease patients in a very detailed computerized way for motor, cognitive and emotional elements for better management of therapies.
With this study, the investigators want to investigate whether computerized speech analysis can be used to reliably and objectively detect fluctuations in motor, mood, and thinking in Parkinson's disease patients.
Even in healthy subjects, speech changes in a situational manner, due to which the investigators will also include healthy subjects as a control group.
Interventions
- Other Dopaminergic OFF drug state
Experiment will be performed without dopaminergic medication - Other DBS OFF state
Turning off the stimulation during experiment - Other Dopaminergic ON drug state
Experiment will be performed with dopaminergic medication - Other DBS ON state
Experiment will be performed with stimulation (ON condition)
Primary outcome measures
- Part I: Changes from baseline in best acoustic speech variables to detect changes of dopaminergic and stimulation motor effect in Parkinson's disease patients [Time frame: Visit 2 (< 3 months)]
- Part II: Changes from baseline in best acoustic and linguistic speech variables to detect changes of dopaminergic and stimulation neuropsychological effect in Parkinson's disease patients [Time frame: Visit 2 (< 3 months)]
- Part III: Changes from baseline in best acoustic and linguistic speech variables to detect changes of dopaminergic and stimulation cognitive effect in Parkinson's disease patients [Time frame: Visit 2 (< 3 months)]
- Part III: Changes from baseline in best acoustic and linguistic speech variables to detect changes of dopaminergic and stimulation cognitive effect in Parkinson's disease patients [Time frame: Visit 2 (< 3 months)]
Secondary outcome measures (4)
- Dyskinesia severity [Time frame: At visit 1 (baseline) and visit 2 (< 3 months)]
- Momentary mood state [Time frame: At visit 1 (baseline) and visit 2 (< 3 months)]
- Momentary anxiety state [Time frame: At visit 1 (baseline) and visit 2 (< 3 months)]
- Bradyphrenia assessment [Time frame: At visit 1 (baseline) and visit 2 (< 3 months)]
Eligibility criteria
Patients with Parkinson's Disease
Inclusion criteria
- Written informed consent
- Idiopathic PD according to the Movement Disorders Society Criteria;
- Age of participants > 30 and ≤ 75 years;
- Treatment with or without bilateral deep brain stimulation in the subthalamic nucleus;
- Fluent in German or French
Exclusion criteria
- Dysarthria caused in addition by a condition other than PD (e.g. stroke, myasthenia);
- Clinical diagnosis of aphasia;
- Brain disease other than Parkinson's disease (e.g. atypical Parkinsonism, Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.).
- Cognitive impairment (Montreal Cognitive Assessment (MoCa) < 24/30 points);
- Depression with acute suicidal ideation
Healthy Controls
Inclusion criteria
- Written informed consent
- Adults from 50-70 years old;
- Fluent in German or French
Exclusion criteria
- Diagnosis of Parkinson's disease;
- Cognitive impairment (Montreal Cognitive Assessment (MoCa) < 24/30 points);
- Suffering from brain disease (e.g. atypical Parkinsonism, Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.);
- Clinical diagnosis of aphasia, dysarthria, and stuttering;
- Suffering from or diagnosed with psychiatric illnesses according to DSM-V criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Czechia · 1 center
- Czech Technical University Prague — Prague
Switzerland · 1 center
- University Hospital Inselspital, Berne — Bern
Identifiers
NCT: NCT05765110 · 2022-01304