An interventional study of Dopaminergic OFF drug state and DBS OFF state in Parkinson Disease, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 2 sites in 2 countries. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Other
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.
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 80 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Parkinson's Disease
Inclusion Criteria:
Exclusion Criteria:
Healthy Controls
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus
Other: Dopaminergic OFF drug state · Other: DBS OFF state · Other: Dopaminergic ON drug state · Other: DBS ON state
All Parkinson's disease patients without bilateral deep brain stimulation (DBS) in the subthalamic nucleus
Other: Dopaminergic OFF drug state · Other: Dopaminergic ON drug state
All healthy volunteers
Experiment will be performed without dopaminergic medication
Turning off the stimulation during experiment
Experiment will be performed with dopaminergic medication
Experiment will be performed with stimulation (ON condition)
Part I: Changes from baseline in best acoustic speech variables to detect changes of dopaminergic and stimulation motor effect in Parkinson's disease patients
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.
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
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.
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
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.
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
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 Stroop test will be used as primary outcomes in this part. Higher scores in Stroop test means worse outcome.
Time frame: Visit 2 (< 3 months)
Dyskinesia severity
Score on Marconi dyskinesia rating scale \[0-28 pts.\]. Higher scores in Marconi dyskinesia rating scale means more severe dyskinesia.
Time frame: At visit 1 (baseline) and visit 2 (< 3 months)
Momentary mood state
Score on Visual Analogue Mood Scale (VAMS) \[0-100 pts.\]. Higher scores in VAMS means better mood.
Time frame: At visit 1 (baseline) and visit 2 (< 3 months)
Momentary anxiety state
Score on Visual Analogue Anxiety Scale (VAAS) \[0-100 pts.\]. Higher scores in VAAS means more anxiety.
Time frame: At visit 1 (baseline) and visit 2 (< 3 months)
Bradyphrenia assessment
Score on Bradyphrenia scale \[0-72 pts.\]. Higher scores in Bradyphrenia scale means more severe bradyphrenia.
Time frame: At visit 1 (baseline) and visit 2 (< 3 months)
Severity of non-motor aspects of experiences of Daily Living
Score on MDS-UPDRS parts I \[0-52 pts.\]. Higher scores in MDS-UPDRS-part I scale means more severe non-motor symptoms on experiences of Daily Living
Time frame: < 2 weeks from the baseline visit
Severity of motor aspects of experiences of Daily Living
Score on MDS-UPDRS parts II \[0-52 pts.\].Higher scores in MDS-UPDRS-part II scale means more severe motor symptoms on experiences of Daily Living
Time frame: < 2 weeks from the baseline visit
Severity of motor fluctuations
Score on MDS-UPDRS parts IV \[0-24 pts.\]. Higher scores in MDS-UPDRS-part IV scale means more severe motor fluctuations
Time frame: < 2 weeks from the baseline visit
Quality of life assessment
Score on Parkinson's Disease Questionnaire, 8 items (PDQ-8) \[0-32 pts.\]. Higher scores in PDQ-8 scale means worse quality of life
Time frame: < 2 weeks from the baseline visit
Dysarthria severity assessment
Score on Voice Handicap Index (VHI) \[0-120 pts.\]. Higher scores in VHI scale means more severe dysarthria (speech impairment)
Time frame: < 2 weeks from the baseline visit
Anxiety and depressive symptomatology
Score on Hospital Anxiety and Depression Scale (HADS) \[0-60 pts.\]. Higher scores in HADS scale means more severe anxiety and depressive symptoms
Time frame: < 2 weeks from the baseline visit
Apathetic symptomatology
Score on Starkstein Apathy Scale (SAS) \[0-42 pts.\]. Higher scores in SAS scale means more severe apathetic symptoms
Time frame: < 2 weeks from the baseline visit
Impulse-control disorders assessment
Score on Questionnaire for impulsive-compulsive disorders in Parkinson's Disease-Rating Scale (QUIP-RS) \[0-112 pts.\]. Higher scores in QUIP-RS scale means more severe impulsive-compulsive disorders
Time frame: < 2 weeks from the baseline visit
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