Clinical trial NCT05765110: SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease
Official title: SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Speech
Emotion
Movement
Cognition
Biomarker
Automated speech analysis
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Czech Technical University in Prague
First posted: 2023-03-13
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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

Primary outcomes:
measure: Part I: Changes from baseline in best acoustic speech variables to detect changes of dopaminergic and stimulation motor effect in Parkinson's disease patients
timeFrame: Visit 2 (< 3 months)
measure: 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
timeFrame: Visit 2 (< 3 months)
measure: 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
timeFrame: Visit 2 (< 3 months)
measure: 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
timeFrame: Visit 2 (< 3 months)
Secondary outcomes:
measure: Dyskinesia severity
timeFrame: At visit 1 (baseline) and visit 2 (< 3 months)
measure: Momentary mood state
timeFrame: At visit 1 (baseline) and visit 2 (< 3 months)
measure: Momentary anxiety state
timeFrame: At visit 1 (baseline) and visit 2 (< 3 months)
measure: Bradyphrenia assessment
timeFrame: At visit 1 (baseline) and visit 2 (< 3 months)
Other outcomes:
measure: Severity of non-motor aspects of experiences of Daily Living
timeFrame: < 2 weeks from the baseline visit
measure: Severity of motor aspects of experiences of Daily Living
timeFrame: < 2 weeks from the baseline visit
measure: Severity of motor fluctuations
timeFrame: < 2 weeks from the baseline visit
measure: Quality of life assessment
timeFrame: < 2 weeks from the baseline visit
measure: Dysarthria severity assessment
timeFrame: < 2 weeks from the baseline visit
measure: Anxiety and depressive symptomatology
timeFrame: < 2 weeks from the baseline visit
measure: Apathetic symptomatology
timeFrame: < 2 weeks from the baseline visit
measure: Impulse-control disorders assessment
timeFrame: < 2 weeks from the baseline visit
Locations:
city: Prague
country: Czechia
facility: Czech Technical University Prague
city: Bern
country: Switzerland
facility: University Hospital Inselspital, Berne
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Paul Krack, Prof.
role: PRINCIPAL_INVESTIGATOR
References: