NCT05182892Recruiting
REducing SPEECH-related Side-effects of Deep Brain Stimulation in Parkinson's Disease Via Automated Speech Analysis
Source: ClinicalTrials.gov · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 22 Dec 2021
- Start date
- 13 Dec 2021
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Parkinson disease
- NCT number
- NCT05182892
What you commit to
- Study type: Interventional
- Planned participants: 45
- From 13 Dec 2021 to the primary completion date, 30 Nov 2025
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Dysarthria caused in addition by a condition other than PD or DBS (e.g. stroke, myasthenia)
- 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
Other
- Clinical diagnosis of aphasia
- Depression with acute suicidal ideation
- Pregnant women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Inselspital, Berne Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| Czech Technical University Prague Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.