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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dopaminergic OFF drug state

    Other intervention

    Experiment will be performed without dopaminergic medication

  • DBS OFF state

    Other intervention

    Turning off the stimulation during experiment

  • Dopaminergic ON drug state

    Other intervention

    Experiment will be performed with dopaminergic medication

  • DBS ON state

    Other intervention

    Experiment will be performed with stimulation (ON condition)

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Parkinson's disease patients with DBSExperimental treatment 4 interventions
Group B: Parkinson's disease patients without DBSExperimental treatment 2 interventions
Group C: Healthy ControlsNo intervention 0 interventions

Trial outcomes

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

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)
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.

Time frame
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.

Time frame
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.

Time frame
Visit 2 (< 3 months)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

1

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
2

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
3

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
4

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Insel Gruppe AG, University Hospital Bern

Lead sponsor

Czech Technical University in Prague

Collaborator