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NCT Number: NCT05765110

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Communication Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Speech Synucleinopathies Verbal Behavior

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Czech Technical University Prague, Prague, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dopaminergic OFF drug state

Other

Experiment will be performed without dopaminergic medication

DBS OFF state

Other

Turning off the stimulation during experiment

Dopaminergic ON drug state

Other

Experiment will be performed with dopaminergic medication

DBS ON state

Other

Experiment will be performed with stimulation (ON condition)

Primary outcomes

  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

    Time frame: Visit 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.

  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

    Time frame: Visit 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.

  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

    Time frame: Visit 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.

  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

    Time frame: Visit 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 Stroop test will be used as primary outcomes in this part. Higher scores in Stroop test means worse outcome.

Secondary outcomes

  1. Dyskinesia severity

    Time frame: At 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.

  2. Momentary mood state

    Time frame: At 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.

  3. Momentary anxiety state

    Time frame: At 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.

  4. Bradyphrenia assessment

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

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

Other outcomes

  1. Severity of non-motor aspects of experiences of Daily Living

    Time frame: < 2 weeks from the baseline visit

    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

  2. Severity of motor aspects of experiences of Daily Living

    Time frame: < 2 weeks from the baseline visit

    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

  3. Severity of motor fluctuations

    Time frame: < 2 weeks from the baseline visit

    Score on MDS-UPDRS parts IV [0-24 pts.]. Higher scores in MDS-UPDRS-part IV scale means more severe motor fluctuations

  4. Quality of life assessment

    Time frame: < 2 weeks from the baseline visit

    Score on Parkinson's Disease Questionnaire, 8 items (PDQ-8) [0-32 pts.]. Higher scores in PDQ-8 scale means worse quality of life

  5. Dysarthria severity assessment

    Time frame: < 2 weeks from the baseline visit

    Score on Voice Handicap Index (VHI) [0-120 pts.]. Higher scores in VHI scale means more severe dysarthria (speech impairment)

  6. Anxiety and depressive symptomatology

    Time frame: < 2 weeks from the baseline visit

    Score on Hospital Anxiety and Depression Scale (HADS) [0-60 pts.]. Higher scores in HADS scale means more severe anxiety and depressive symptoms

  7. Apathetic symptomatology

    Time frame: < 2 weeks from the baseline visit

    Score on Starkstein Apathy Scale (SAS) [0-42 pts.]. Higher scores in SAS scale means more severe apathetic symptoms

  8. Impulse-control disorders assessment

    Time frame: < 2 weeks from the baseline visit

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Mario Sousa, MD

CONTACT

[email protected]

31 664 23 49 ext. +41

Paul Krack, Prof.

CONTACT

[email protected]

31 66 4 03 71 ext. +41

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Czech Technical University in Prague

Registry information

Acronym: EMO-SPEECH-PD

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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