Change of stimulation amplitudes in dopaminergic OFF drug state
Change of stimulation amplitudes in dopaminergic OFF drug state: Change of stimulation amplitudes during experiment in dopaminergic OFF drug state.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Part 1: Identification of the most sensitive and specific speech variables — At visit 1 (baseline visit) Identification of the most sensitive and specific speech variables of an automated acoustic analysis method, for STN-DBS-related improvement as well as worsening of speech in PD patients, under the two conditions (dopaminergic ON and OFF drug state).
Speech variables will be extracted from the automated acoustic analysis.
Part 1: Identification of the most sensitive and specific speech variables — At visit 2 (≤4 weeks after visit 1) Identification of the most sensitive and specific speech variables of an automated acoustic analysis method, for STN-DBS-related improvement as well as worsening of speech in PD patients, under the two conditions (dopaminergic ON and OFF drug state).
Speech variables will be extracted from the automated acoustic analysis.
Part 2, Speech analysis: Investigation of spatial overlap of volume of tissue activated (VTA) and the corticobulbar/corticospinal tract — 12 months Investigation of spatial overlap of tissue activated (VTA) and the corticobulbar/corticospinal tract, in relation to the dysarthria-worsening.
Part 2, Speech analysis: Investigation of spatial overlap of VTA and the dorsolateral (sensorimotor) STN — 12 months Investigation of spatial overlap of VTA and the dorsolateral (sensorimotor) STN in relation to improvement of PD-related dysarthria.
Part 3: Perceptual speech ratings — At baseline visit To test if the model 'perceptual speech ratings' explains subjective improvement of STN-DBS induced dysarthria.
Perceptive rating will be performed by three experienced speech therapists, who will rate speech on a visual analogue scale (VAS).
Part 3: Perceptual speech ratings — At visit 1 (0-6 weeks after baseline) To test if the model 'perceptual speech ratings' explains subjective improvement of STN-DBS induced dysarthria.
Perceptive rating will be performed by three experienced speech therapists, who will rate speech on a visual analogue scale (VAS).
Part 3: Perceptual speech ratings — At visit 2 (6-12 weeks after visit 1) To test if the model 'perceptual speech ratings' explains subjective improvement of STN-DBS induced dysarthria.
Perceptive rating will be performed by three experienced speech therapists, who will rate speech on a visual analogue scale (VAS).
Part 3: Automated speech analysis — At baseline visit To test if the model 'automated speech analysis' explains subjective improvement of STN-DBS induced dysarthria.
From the automated speech analysis, only the speech parameters explaining most of the variance in the model from part 2 will be included in the analysis.
Part 3: Automated speech analysis — At visit 1 (0-6 weeks after baseline) To test if the model 'automated speech analysis' explains subjective improvement of STN-DBS induced dysarthria.
From the automated speech analysis, only the speech parameters explaining most of the variance in the model from part 2 will be included in the analysis.
Part 3: Automated speech analysis — At visit 2 (6-12 weeks after visit 1) To test if the model 'automated speech analysis' explains subjective improvement of STN-DBS induced dysarthria.
From the automated speech analysis, only the speech parameters explaining most of the variance in the model from part 2 will be included in the analysis.
Trial sites (2)
Facility
City
Region
Status
Czech Technical University Prague
Prague
Czechia
Active Not Recruiting
University Hospital Inselspital, Berne
Bern
Switzerland
Recruiting
More Insel Gruppe AG, University Hospital Bern trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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