An observational study in Parkinson's Disease and Deep Brain Stimulation, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 4 sites in 3 countries. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
The primary objective of the study is to determine if subthalamic nucleus (STN) deep brain stimulation (DBS) using the Vercise directional leads improves neuropsychiatric state and neuropsychiatric fluctuations 12 months after surgery in a large consecutive series of STN-DBS Parkinson's disease (PD) patients.
This project of further use of health-related data with consent by the participants is a prospective, international project to evaluate the improvement of neuropsychiatric symptoms and the quality of life 12 months after surgery in a large consecutive series of STN-DBS PD patients using novel implantable Neurostimulator Systems (Boston Scientific). The project will investigate if a fine tuning of the STN-DBS settings could alleviate neuropsychiatric fluctuations, apathy as well as DBS-induced dysarthria and global motor state. The tuning is performed in agreement with the instruction for use of all devices used. Further objectives are validation of new tools that are presently entering clinical routine in optimizing postoperative management like individual current sources, steering, imaging of volume of tissue activated, and beta-oscillations.
The data originates from patients suffering from levodopa-responsive PD which are not adequately controlled by dopaminergic medication and therefore receive STN-DBS as a routine standard of care with routinely collected data.
In total 110 patients who are candidates for STN-DBS will be enrolled in four participating sites in Switzerland and the EU.
The project population consists of PD patients suffering from levodopa-responsive PD which are not adequately controlled by dopaminergic medication and therefore receive STN-DBS as a routine standard of care.
For all subjects:
Exclusion Criteria:
Patients diagnosed with apathy
Other: Steering
Patients diagnosed with dysarthria
Other: Steering
Patients diagnosed with neither apathy nor dysarthria
Patients diagnosed with apathy as well as dysarthria
Other: Steering
Fine tuning of the STN-DBS settings
Evaluation of non-motor fluctuations
Evaluation of the Neuropsychiatric Fluctuations Scale (NFS) in different states (ON/OFF) to evaluate if non-motor fluctuations are present. The bigger the difference between the two subscores ('ON psychological state' and 'OFF psychological sate') in the different states are, the more non-motor fluctuations are present.
Time frame: Follow-up ≤ 5 Weeks
Evaluation of motor improvement
Motor improvement following STN-DBS using the Vercise directional leads will be assessed by comparing MDS-UPDRS III score (International Parkinson and Movement Disorder Society) during the study in different states (ON/OFF). The minimum and maximum values are: 0-132, where a higher score means a worse outcome.
Time frame: Follow-up ≤ 5 Weeks
Evaluation of STN-DBS induced dysarthria
Dysarthria will be measured during the study by Voice Handicap Index 30 (VHI) scale. The minimum and maximum values are: 0-120, where a higher score means a worse outcome.
Time frame: Follow-up ≤ 5 Weeks
Evaluation of postoperative apathy
Apathy will be measured during the study by Dimensional Apathy Scale (DAS). The minimum and maximum values are: 0-72, where a higher score means a worse outcome.
Time frame: Follow-up ≤ 5 Weeks
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern