SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease
NCT ID: NCT05765110
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-01-03
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Parkinson's disease patients with DBS
All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus
Dopaminergic OFF drug state
Experiment will be performed without dopaminergic medication
DBS OFF state
Turning off the stimulation during experiment
Dopaminergic ON drug state
Experiment will be performed with dopaminergic medication
DBS ON state
Experiment will be performed with stimulation (ON condition)
Parkinson's disease patients without DBS
All Parkinson's disease patients without bilateral deep brain stimulation (DBS) in the subthalamic nucleus
Dopaminergic OFF drug state
Experiment will be performed without dopaminergic medication
Dopaminergic ON drug state
Experiment will be performed with dopaminergic medication
Healthy Controls
All healthy volunteers
No interventions assigned to this group
Interventions
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Dopaminergic OFF drug state
Experiment will be performed without dopaminergic medication
DBS OFF state
Turning off the stimulation during experiment
Dopaminergic ON drug state
Experiment will be performed with dopaminergic medication
DBS ON state
Experiment will be performed with stimulation (ON condition)
Eligibility Criteria
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Inclusion Criteria
* 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
* Written informed consent
* Adults from 50-70 years old;
* Fluent in German or French
Exclusion Criteria
* 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
* 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
30 Years
75 Years
ALL
Yes
Sponsors
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Czech Technical University in Prague
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Paul Krack, Prof.
Role: PRINCIPAL_INVESTIGATOR
Insel Gruppe AG, University Hospital Bern
Locations
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Czech Technical University Prague
Prague, , Czechia
University Hospital Inselspital, Berne
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-01304
Identifier Type: -
Identifier Source: org_study_id
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