SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease (EMO-SPEECH-PD)

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Dopaminergic OFF drug state; Other: DBS OFF state; Other: Dopaminergic ON drug state; Other: DBS ON state

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Sousa, MD; Phone Number: +41 31 664 23 49; Email: mario.sousa@insel.ch
• Study Contact Backup: Name: Paul Krack, Prof.; Phone Number: +41 31 66 4 03 71; Email: paul.krack@insel.ch

Study Locations

• Czechia
  • Prague, Czechia, 166 27
    • Active, not recruiting
    • Czech Technical University Prague
• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • University Hospital Inselspital, Berne
    • Contact: Mario Sousa, MD; Phone Number: +41 31 664 23 49; Email: mario.sousa@insel.ch
    • Contact: Paul Krack, Prof.; Phone Number: +41 31 66 4 03 71; Email: paul.krack@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parkinson's disease patients with DBS; All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus	Other: Dopaminergic OFF drug state; Experiment will be performed without dopaminergic medication; Other: DBS OFF state; Turning off the stimulation during experiment; Other: Dopaminergic ON drug state; Experiment will be performed with dopaminergic medication; Other: DBS ON state; Experiment will be performed with stimulation (ON condition)
Experimental: Parkinson's disease patients without DBS; All Parkinson's disease patients without bilateral deep brain stimulation (DBS) in the subthalamic nucleus	Other: Dopaminergic OFF drug state; Experiment will be performed without dopaminergic medication; Other: Dopaminergic ON drug state; Experiment will be performed with dopaminergic medication
No Intervention: Healthy Controls; All healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Visit 2 (< 3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyskinesia severity	Score on Marconi dyskinesia rating scale [0-28 pts.]. Higher scores in Marconi dyskinesia rating scale means more severe dyskinesia.	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.	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.	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.	At visit 1 (baseline) and visit 2 (< 3 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	< 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	< 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	< 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	< 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)	< 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	< 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	< 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	< 2 weeks from the baseline visit

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: Czech Technical University in Prague
• Investigators: Principal Investigator: Paul Krack, Prof., University Hospital Inselspital, Berne

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Biomarker; Emotion; Cognition; Movement; Speech; Automated speech analysis
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Cardiotonic Agents; Dopamine Agents; Sympathomimetics; Dopamine; Dopamine Agonists
• Other Study ID Numbers: 2022-01304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No