๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ 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 โค 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
๐
What it tests
- Change of stimulation amplitudes in dopaminergic OFF drug state
Czech Technical University Prague
Prague, Czechia
University Hospital Inselspital, Berne
Bern, Switzerland
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.