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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Dopaminergic OFF drug state
  Experiment will be performed without dopaminergic medication
• Другое DBS OFF state
  Turning off the stimulation during experiment
• Другое Dopaminergic ON drug state
  Experiment will be performed with dopaminergic medication
• Другое DBS ON state
  Experiment will be performed with stimulation (ON condition)

Первичные конечные точки

• Part I: Changes from baseline in best acoustic speech variables to detect changes of dopaminergic and stimulation motor effect in Parkinson's disease patients [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Visit 2 (< 3 months)]

Вторичные конечные точки (4)

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

Критерии участия

Patients with Parkinson's Disease

Критерии включения

• 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

Критерии исключения

• 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

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Чехия · 1 центр

• Czech Technical University Prague — Prague

Швейцария · 1 центр

• University Hospital Inselspital, Berne — Bern

Идентификаторы

NCT: NCT05765110 · 2022-01304

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗