Improving speech in Parkinson's patients with deep brain stimulation
REducing SPEECH-related Side-effects of Deep Brain Stimulation in Parkinson's Disease Via Automated Speech Analysis
This study is testing if deep brain stimulation can improve speech quality in people with Parkinson's disease while also looking at how medication affects their speech.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 2 sites (Prague and 1 other locations) |
| Trial ID | NCT05182892 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance speech quality in patients with Parkinson's disease who experience speech disorders due to deep brain stimulation (DBS) of the subthalamic nucleus. By utilizing automated acoustic analysis, the researchers will identify specific speech variables that can help differentiate between speech improvements and side effects caused by DBS. The study will assess patients in both medicated and unmedicated states to gather comprehensive data on their speech patterns. The ultimate goal is to reduce the incidence of dysarthria associated with DBS while improving overall communication abilities.
Who should consider this trial
Good fit: Ideal candidates include individuals with idiopathic Parkinson's disease who have undergone bilateral deep brain stimulation and experience speech difficulties related to the treatment.
Not a fit: Patients whose speech disorders are caused by conditions other than Parkinson's disease or deep brain stimulation, such as stroke or myasthenia, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for Parkinson's patients by enhancing their speech capabilities.
How similar studies have performed: While there have been studies on speech disorders in Parkinson's disease, the specific use of automated acoustic analysis in conjunction with DBS is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Prague and 1 other locations
- Czech Technical University Prague — Prague, Czechia (Active_not_recruiting)
- University Hospital Inselspital, Berne — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Paul Krack, Prof. — Insel Gruppe AG, University Hospital Bern
- Study coordinator: Paul Krack, Prof.
- Email: paul.krack@insel.ch
- Phone: 31 632 21 68
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.