Language as an Indicator of Emotions, Motor Skills, and Cognition in Patients with Parkinson's Disease
Zusammenfassung der Studie
Parkinson's disease affects mobility, thought processes, and mood. Our language is one of the most complex programs of humans. It simultaneously contains information about mobility, thinking, and mood. These three levels of mobility, thinking, and mood are subject to spontaneous fluctuations and can be influenced by external stimuli such as emotionally charged images. Furthermore, these three levels are influenced on one hand by Parkinson's disease itself and on the other hand by its treatment with medications or deep brain stimulation (DBS). For this reason, we want to study the language of Parkinson's patients in great detail regarding motor, cognitive, and emotional elements using computer-assisted methods for better therapy management. With this study, we aim to investigate whether computer-assisted speech analysis can reliably and objectively capture the fluctuations of mobility, mood, and thinking in Parkinson's patients. Even in healthy individuals, language changes depending on the situation, which is why we also want to include healthy subjects as a control group.
(BASEC)
Untersuchte Intervention
- Parkinson's patients without deep brain stimulation will undergo examinations; 1) once without Parkinson's medications (when the effect of the medications wears off), the so-called OFF state and 2) once with Parkinson's medications, when the medications are working optimally (ON state). - Parkinson's patients with deep brain stimulation (DBS) will undergo examinations without the influence of Parkinson's medication (OFF state); 1) once with DBS stimulation turned on (ON stimulation) and 2) once with DBS stimulation turned off (OFF stimulation). Furthermore, the examinations will be repeated in the medication ON state (with regular Parkinson's medication); 3) once with stimulation turned on (ON stimulation) and 4) once with stimulation turned off (OFF stimulation). Healthy individuals from the control group will undergo the examinations only once.
(BASEC)
Untersuchte Krankheit(en)
This research project includes Parkinson's patients with and without deep brain stimulation (DBS). Additionally, healthy individuals will also be recruited for the control group, who are in good general health and do not suffer from Parkinson's disease or any other neurological or psychiatric condition.
(BASEC)
Parkinson's patients: - Age between 30-75 years - Parkinson's patients treated without or with deep brain stimulation (in the subthalamic nucleus) - Fluent in German or French (written and spoken) Control group (healthy subjects): - All individuals fluent in German or French between 50-70 years, who are in good general health. (BASEC)
Ausschlusskriterien
Parkinson's patients: - Speech disorder caused by conditions other than Parkinson's - Clinical diagnosis of a speech disorder (aphasia) - Psychiatric conditions or other conditions affecting the brain - Inability to follow the study procedures, e.g., due to speech problems, mental disorders, or dementia Control group (healthy subjects): - Individuals suffering from Parkinson's disease or another neurological or psychiatric condition (BASEC)
Studienstandort
Bern
(BASEC)
Sponsor
Insel Gruppe AG, University Hospital Bern
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Mario Sousa
+41 31 66 4 23 49
mario.sousa@clutterinsel.chInsel Gruppe AG, University Hospital Bern
(BASEC)
Allgemeine Auskünfte
Insel Gruppe AG, University Hospital Bern
31 66 4 03 7131 66 4 03 71
mario.sousa@clutterinsel.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
09.12.2022
(BASEC)
ICTRP Studien-ID
NCT05765110 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease (EMO-SPEECH-PD) (BASEC)
Wissenschaftlicher Titel
SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease (ICTRP)
Öffentlicher Titel
SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease (ICTRP)
Untersuchte Krankheit(en)
Parkinson Disease (ICTRP)
Untersuchte Intervention
Other: Dopaminergic OFF drug stateOther: DBS OFF stateOther: Dopaminergic ON drug stateOther: DBS ON state (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Part I: Changes from baseline in best acoustic speech variables to detect changes of dopaminergic and stimulation motor effect in Parkinson's disease patients;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;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;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 (ICTRP)
Dyskinesia severity;Momentary mood state;Momentary anxiety state;Bradyphrenia assessment (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Czech Technical University in Prague (ICTRP)
Weitere Kontakte
Paul Krack, Prof.Paul Krack, Prof.Paul Krack, Prof., paul.krack@insel.chpaul.krack@insel.ch, 31 66 4 03 7131 66 4 03 71, Insel Gruppe AG, University Hospital Bern (ICTRP)
Sekundäre IDs
2022-01304 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05765110 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar