NCT05182892 REducing SPEECH-related Side-effects of Deep Brain Stimulation in Parkinson's Disease Via Automated Speech Analysis
| NCT ID | NCT05182892 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2021-12-13 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2021-12-13 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 STN-DBS-induced dysarthria.
Eligibility 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
Contact & Investigator
Paul Krack, Prof.
PRINCIPAL INVESTIGATOR
Insel Gruppe AG, University Hospital Bern
Frequently Asked Questions
Who can join the NCT05182892 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05182892 currently recruiting?
Yes, NCT05182892 is actively recruiting participants. Contact the research team at paul.krack@insel.ch for enrollment information.
Where is the NCT05182892 trial being conducted?
This trial is being conducted at Prague, Czechia, Bern, Switzerland.
Who is sponsoring the NCT05182892 clinical trial?
NCT05182892 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Paul Krack, Prof. at Insel Gruppe AG, University Hospital Bern. The trial plans to enroll 45 participants.
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