Can Subthalamic Stimulation Using Directional Electrodes Improve Postoperative Management in Parkinson's Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Deep Brain Stimulation
- Parkinson's Disease
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
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 implan...
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.
Tracking Information
- NCT #
- NCT04578678
- Collaborators
- Boston Scientific Corporation
- Investigators
- Principal Investigator: Ines Debove, MD Insel Gruppe AG University Hospital Bern