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Parkinson DiseaseEMO-SPEECH-PDNCT05765110

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

A study testing Dopaminergic OFF drug state, DBS OFF state and Dopaminergic ON drug state in people with Parkinson Disease, run by Insel Gruppe AG, University Hospital Bern at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Parkinson Disease
What is being tested?
Dopaminergic OFF drug state, DBS OFF state and Dopaminergic ON drug state
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesin 2 countries
Study dates
3 Jan 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
  • Written informed consent
  • Adults from 50-70 years old;
  • Fluent in German or French

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Paul Krack, Prof. contact

31 66 4 03 71 ext. +41

paul.krack@insel.ch

Mario Sousa, MD contact

31 664 23 49 ext. +41

mario.sousa@insel.ch

2 sites in 2 countries

Czechia1 site

  • Czech Technical University Prague

    Prague, 166 27

    Active, not recruiting

Other trials in Czechia

Switzerland1 site, 1 recruiting

  • University Hospital Inselspital, Berne

    Bern, 3010

    Paul Krack, Prof., 31 66 4 03 71 ext. +41, paul.krack@insel.ch

    Mario Sousa, MD, 31 664 23 49 ext. +41, mario.sousa@insel.ch

    Recruiting

Other trials in Switzerland

About this study

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.

Read the 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.

Being tested
Dopaminergic OFF drug state, DBS OFF state, Dopaminergic ON drug state, DBS ON state
Keywords
Speech, Emotion, Movement, Cognition, Biomarker, Automated speech analysis
Medical subject headings
Parkinson Disease, Speech

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dopaminergic OFF drug stateOther

    Experiment will be performed without dopaminergic medication

  • DBS OFF stateOther

    Turning off the stimulation during experiment

  • Dopaminergic ON drug stateOther

    Experiment will be performed with dopaminergic medication

  • DBS ON stateOther

    Experiment will be performed with stimulation (ON condition)

Study groups in NCT05765110
Study groupRoleWhat they receive
Parkinson's disease patients with DBSExperimentalAll Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus
Receives: Other: Dopaminergic OFF drug state; Other: DBS OFF state; Other: Dopaminergic ON drug state; Other: DBS ON state
Parkinson's disease patients without DBSExperimentalAll Parkinson's disease patients without bilateral deep brain stimulation (DBS) in the subthalamic nucleus
Receives: Other: Dopaminergic OFF drug state; Other: Dopaminergic ON drug state
Healthy ControlsNo interventionAll healthy volunteers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Visit 2 (< 3 months)

  2. 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.

    Measured: Visit 2 (< 3 months)

  3. 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.

    Measured: Visit 2 (< 3 months)

  4. 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.

    Measured: Visit 2 (< 3 months)

Secondary outcomes (4)

  1. Dyskinesia severity

    Score on Marconi dyskinesia rating scale [0-28 pts.]. Higher scores in Marconi dyskinesia rating scale means more severe dyskinesia.

    Measured: At visit 1 (baseline) and visit 2 (< 3 months)

  2. Momentary mood state

    Score on Visual Analogue Mood Scale (VAMS) [0-100 pts.]. Higher scores in VAMS means better mood.

    Measured: At visit 1 (baseline) and visit 2 (< 3 months)

  3. Momentary anxiety state

    Score on Visual Analogue Anxiety Scale (VAAS) [0-100 pts.]. Higher scores in VAAS means more anxiety.

    Measured: At visit 1 (baseline) and visit 2 (< 3 months)

  4. Bradyphrenia assessment

    Score on Bradyphrenia scale [0-72 pts.]. Higher scores in Bradyphrenia scale means more severe bradyphrenia.

    Measured: At visit 1 (baseline) and visit 2 (< 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2023
  2. Study start3 Jan 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05765110
Sponsor's protocol ID
2022-01304
Acronym
EMO-SPEECH-PD
Status last verified
May 2026
First submitted
11 Jan 2023
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dopaminergic OFF drug state, DBS OFF state and Dopaminergic ON drug state in people with Parkinson Disease, run by Insel Gruppe AG, University Hospital Bern at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paul Krack, Prof. (31 66 4 03 71 ext. +41, paul.krack@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Visit 2 (< 3 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05765110.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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