Improving speech in Parkinson's patients with deep brain stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University Hospital Inselspital, Berne
  Bern, Switzerland Recruiting
• Czech Technical University Prague
  Prague, Czechia Active not 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.