Skip to main content
Clinical Trials/NCT05765110
NCT05765110
Recruiting
N/A

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

Insel Gruppe AG, University Hospital Bern2 sites in 2 countries80 target enrollmentJanuary 3, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Insel Gruppe AG, University Hospital Bern
Enrollment
80
Locations
2
Primary Endpoint
Part I: Changes from baseline in best acoustic speech variables to detect changes of dopaminergic and stimulation motor effect in Parkinson's disease patients
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2023
End Date
March 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Dyskinesia severity(At visit 1 (baseline) and visit 2 (< 3 months))
  • Momentary mood state(At visit 1 (baseline) and visit 2 (< 3 months))
  • Momentary anxiety state(At visit 1 (baseline) and visit 2 (< 3 months))
  • Bradyphrenia assessment(At visit 1 (baseline) and visit 2 (< 3 months))

Study Sites (2)

Loading locations...

Similar Trials