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

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Parkinson Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05765110

2022-01304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Parkinson's disease patients with DBS

Experimental group

Description:

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

Treatment:

Other: Dopaminergic ON drug state

Other: DBS OFF state

Other: Dopaminergic OFF drug state

Other: DBS ON state

Parkinson's disease patients without DBS

Experimental group

Description:

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

Treatment:

Other: Dopaminergic ON drug state

Other: Dopaminergic OFF drug state

Healthy Controls

No Intervention group

Description:

All healthy volunteers