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SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease

SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05765110
Acronym
EMO-SPEECH-PD
Enrollment
80
Registered
2023-03-13
Start date
2023-01-03
Completion date
2026-12-31
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Speech, Emotion, Movement, Cognition, Biomarker, Automated speech analysis

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.

Interventions

OTHERDopaminergic OFF drug state

Experiment will be performed without dopaminergic medication

OTHERDBS OFF state

Turning off the stimulation during experiment

OTHERDopaminergic ON drug state

Experiment will be performed with dopaminergic medication

OTHERDBS ON state

Experiment will be performed with stimulation (ON condition)

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER
Czech Technical University in Prague
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Part I: Changes from baseline in best acoustic speech variables to detect changes of dopaminergic and stimulation motor effect in Parkinson's disease patientsVisit 2 (< 3 months)A speech analyser software will allow extraction of basic motor acoustic speech features. The extracted variables that better index the dopaminergic medication or stimulation motor effect assessed with Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III - motor score \[0-132 pts.\] will be used as primary outcomes in this part. Higher scores in MDS-UPDRS part III means more severe motor symptoms.
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 patientsVisit 2 (< 3 months)A speech analyser software will allow extraction of basic acoustic speech features. For the linguistic domain several natural language variables will be extracted covering domains such as linguistic sense, coherence, and emotionality. The extracted variables that better index the dopaminergic medication or stimulation emotional effect assessed with Neuropsychiatric fluctuations scale (NFS) \[0-60 pts.\] will be used as primary outcomes in this part. Higher scores in NFS means more severe neuropsychiatric fluctuations.
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 patientsVisit 2 (< 3 months)A speech analyser software will allow extraction of basic acoustic speech features. For the linguistic domain several natural language variables will be extracted covering domains such as linguistic sense, coherence, and emotionality. The extracted variables that better index the dopaminergic medication or stimulation cognitive effect assessed with verbal fluency task will be used as primary outcomes in this part. Higher scores in Fluency task means better outcome.

Secondary

MeasureTime frameDescription
Dyskinesia severityAt visit 1 (baseline) and visit 2 (< 3 months)Score on Marconi dyskinesia rating scale \[0-28 pts.\]. Higher scores in Marconi dyskinesia rating scale means more severe dyskinesia.
Momentary mood stateAt visit 1 (baseline) and visit 2 (< 3 months)Score on Visual Analogue Mood Scale (VAMS) \[0-100 pts.\]. Higher scores in VAMS means better mood.
Momentary anxiety stateAt visit 1 (baseline) and visit 2 (< 3 months)Score on Visual Analogue Anxiety Scale (VAAS) \[0-100 pts.\]. Higher scores in VAAS means more anxiety.
Bradyphrenia assessmentAt visit 1 (baseline) and visit 2 (< 3 months)Score on Bradyphrenia scale \[0-72 pts.\]. Higher scores in Bradyphrenia scale means more severe bradyphrenia.

Countries

Czechia, Switzerland

Contacts

CONTACTPaul Krack, Prof.
paul.krack@insel.ch31 66 4 03 71
CONTACTMario Sousa, MD
mario.sousa@insel.ch31 664 23 49
PRINCIPAL_INVESTIGATORPaul Krack, Prof.

Insel Gruppe AG, University Hospital Bern

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026