Status:
RECRUITING
REducing SPEECH-related Side-effects of Deep Brain Stimulation in Parkinson's Disease Via Automated Speech Analysis
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Czech Technical University in Prague
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is an effective treatment of L-dopa sensitive motor symptoms of Parkinson's disease (PD) but its effects on speech are equivocal. Although...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05182892
Start Date
December 13 2021
End Date
February 28 2026
Last Update
April 9 2025
Active Locations (2)
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1
Czech Technical University Prague
Prague, Czechia, 166 27
2
University Hospital Inselspital, Berne
Bern, Switzerland, 3010