REducing SPEECH-related Side-effects of Deep Brain Stimulation in Parkinson's Disease Via Automated Speech Analysis
Recruiting now · Not applicable
Conditions studied: Parkinson Disease
In brief
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.
Key facts
- Study ID
- NCT05182892
- Run by
- Insel Gruppe AG, University Hospital Bern
- People needed
- 45
- Starts
- 2021-12-13
- Expected to finish
- 2026-02-28
- Last updated by the study team
- 2025-04-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- University Hospital Inselspital, Berne — Bern, Switzerland (enrolling)
- Czech Technical University Prague — Prague, Czechia
Full record on ClinicalTrials.gov
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