Back to results

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

Primary Purpose

Parkinson Disease

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Dopaminergic OFF drug state

DBS OFF state

Dopaminergic ON drug state

DBS ON state

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring Speech, Emotion, Movement, Cognition, Biomarker, Automated speech analysis

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Czech Technical University Prague
University Hospital Inselspital, BerneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Parkinson's disease patients with DBS

Parkinson's disease patients without DBS

Healthy Controls

Arm Description

All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus

All Parkinson's disease patients without bilateral deep brain stimulation (DBS) in the subthalamic nucleus

All healthy volunteers

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

Dyskinesia severity

Score on Marconi dyskinesia rating scale [0-28 pts.]. Higher scores in Marconi dyskinesia rating scale means more severe dyskinesia.

Momentary mood state

Score on Visual Analogue Mood Scale (VAMS) [0-100 pts.]. Higher scores in VAMS means better mood.

Momentary anxiety state

Score on Visual Analogue Anxiety Scale (VAAS) [0-100 pts.]. Higher scores in VAAS means more anxiety.

Bradyphrenia assessment

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

Full Information

NCT ID

NCT05765110

First Posted

January 11, 2023

Last Updated

February 28, 2023

Sponsor

Insel Gruppe AG, University Hospital Bern

Collaborators

Czech Technical University in Prague

1. Study Identification

Unique Protocol Identification Number

NCT05765110

Brief Title

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

Acronym

EMO-SPEECH-PD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 3, 2023 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Insel Gruppe AG, University Hospital Bern

Collaborators

Czech Technical University in Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Speech, Emotion, Movement, Cognition, Biomarker, Automated speech analysis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Parkinson's disease patients with DBS

Arm Type

Experimental

Arm Description

All Parkinson's disease patients with bilateral deep brain stimulation (DBS) in the subthalamic nucleus

Arm Title

Parkinson's disease patients without DBS

Arm Type

Experimental

Arm Description

All Parkinson's disease patients without bilateral deep brain stimulation (DBS) in the subthalamic nucleus

Arm Title

Healthy Controls

Arm Type

No Intervention

Arm Description

All healthy volunteers

Intervention Type

Other

Intervention Name(s)

Dopaminergic OFF drug state

Intervention Description

Experiment will be performed without dopaminergic medication

Intervention Type

Other

Intervention Name(s)

DBS OFF state

Intervention Description

Turning off the stimulation during experiment

Intervention Type

Other

Intervention Name(s)

Dopaminergic ON drug state

Intervention Description

Experiment will be performed with dopaminergic medication

Intervention Type

Other

Intervention Name(s)

DBS ON state

Intervention Description

Experiment will be performed with stimulation (ON condition)

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Visit 2 (< 3 months)

Title

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

Description

Time Frame

Visit 2 (< 3 months)

Title

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

Description

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)

Title

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

Description

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 Outcome Measure Information:

Title

Dyskinesia severity

Description

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)

Title

Momentary mood state

Description

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)

Title

Momentary anxiety state

Description

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)

Title

Bradyphrenia assessment

Description

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 Pre-specified Outcome Measures:

Title

Severity of non-motor aspects of experiences of Daily Living

Description

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