REducing SPEECH-related Side-effects of Deep Brain Stimulation in Parkinson's Disease Via Automated Speech Analysis
Recruiting · NCT05182892 · Interventional (participants receive a specific treatment) · Lead sponsor: Insel Gruppe AG, University Hospital Bern
View the official record on ClinicalTrials.gov →Interventions studied
Change of stimulation amplitudes in dopaminergic OFF drug state
What this trial is about
The investigators' objective is to improve L-dopa sensitive PD-related dysarthria and at the same time reduce DBS-induced speech disorders with the help of automated acoustic analysis in patients with STN-DBS-induced dysarthria.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Idiopathic Parkinson-Syndrome according to the Movement Disorders Society Criteria
- Treatment with bilateral deep brain stimulation in the subthalamic nucleus (for parts 1, 2 and 3)
- Time since DBS-STN operation ≥ 3 month (for parts 1, 2 and 3)
- Able to give informed consent as documented by signature
- Fluent in Swiss-German or German
- STN-DBS-induced dysarthria. In an operational definition, all PD-patients who reported -worsening of speech time-locked to STN-DBS implantation or patients with dysarthria on chronic stimulation improving with reduction of stimulation amplitudes in the context of postoperative routine follow up will be defined as having STN-DBS-induced dysarthria
Exclusion criteria
- Dysarthria caused in addition by a condition other than PD or DBS (e.g. stroke, myasthenia)
- Clinical diagnosis of aphasia
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders and dementia. A Montreal Cognitive Assesment (MoCa) will be performed and patients with ≤ 20 of 30 points will be excluded
- Change of parkinsonian medication in the last four weeks prior to inclusion in part 1 and 3
- Change of STN-DBS parameters in the last four weeks prior to inclusion (for parts 1 and 3)
- Depression with acute suicidal ideation
- Pregnant women
Where it is running
2 locations listed.
- University Hospital Inselspital, Berne - Bern, Switzerland
- Czech Technical University Prague - Prague, Czechia