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

NCT05765110 | Recruiting

• 1 other identifier: 2022-01304
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

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.

Conditions

Parkinson Disease

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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)

Other Outcomes (8)

• Severity of non-motor aspects of experiences of Daily Living

  < 2 weeks from the baseline visit

• Severity of motor aspects of experiences of Daily Living

  < 2 weeks from the baseline visit

• Severity of motor fluctuations

  < 2 weeks from the baseline visit

Study Arms (3)

Parkinson's disease patients with DBS

EXPERIMENTAL

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

Other: Dopaminergic OFF drug state; Other: DBS OFF state; Other: Dopaminergic ON drug state; Other: DBS ON state

Parkinson's disease patients without DBS

EXPERIMENTAL

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

Other: Dopaminergic OFF drug state; Other: Dopaminergic ON drug state

Healthy Controls

NO INTERVENTION

All healthy volunteers

Interventions

Dopaminergic OFF drug state OTHER

Experiment will be performed without dopaminergic medication

Parkinson's disease patients with DBS; Parkinson's disease patients without DBS

DBS OFF state OTHER

Turning off the stimulation during experiment

Parkinson's disease patients with DBS

Dopaminergic ON drug state OTHER

Experiment will be performed with dopaminergic medication

Parkinson's disease patients with DBS; Parkinson's disease patients without DBS

DBS ON state OTHER

Experiment will be performed with stimulation (ON condition)

Parkinson's disease patients with DBS

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Written informed consent
• Adults from 50-70 years old;
• Fluent in German or French
• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Czech Technical University in Prague: collaborator

Study Sites (2)

Czech Technical University Prague

Prague, 166 27, Czechia

ACTIVE NOT RECRUITING

University Hospital Inselspital, Berne

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Speech

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Verbal Behavior; Communication; Behavior

Study Officials

• Paul Krack, Prof.

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Krack, Prof.

CONTACT

31 66 4 03 71; paul.krack@insel.ch

Mario Sousa, MD

CONTACT

31 664 23 49; mario.sousa@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: March 13, 2023
• Study Start: January 3, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); CZ (1)