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

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Other: Dopaminergic OFF drug state; Other: DBS OFF state; Other: Dopaminergic ON drug state; Other: DBS ON state

• Registration Number: NCT05765110
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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.

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 Timeline

• Study Start: 2023-01-03
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-10-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parkinson's disease patients with DBS	Dopaminergic OFF drug state	All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus
Parkinson's disease patients with DBS	DBS ON state	All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus
Parkinson's disease patients with DBS	DBS OFF state	All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus
Parkinson's disease patients with DBS	Dopaminergic ON drug state	All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus
Parkinson's disease patients without DBS	Dopaminergic OFF drug state	All Parkinson's disease patients without bilateral deep brain stimulation (DBS) in the subthalamic nucleus
Parkinson's disease patients without DBS	Dopaminergic ON drug state	All Parkinson's disease patients without bilateral deep brain stimulation (DBS) in the subthalamic nucleus

Primary Outcome Measures

Name	Time	Method
Part I: Changes from baseline in best acoustic speech variables to detect changes of dopaminergic and stimulation motor effect in Parkinson's disease patients	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.
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	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.
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	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.

Secondary Outcome Measures

Name	Time	Method
Dyskinesia severity	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.
Momentary mood state	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.
Momentary anxiety state	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.
Bradyphrenia assessment	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.

Trial Locations

Locations (2)

Czech Technical University Prague; 🇨🇿 Prague, Czechia

University Hospital Inselspital, Berne; 🇨🇭 Bern, Switzerland