132
Participants
Start Date
January 3, 2024
Primary Completion Date
December 15, 2025
Study Completion Date
March 15, 2026
Imaging-based programming
Preferred contact point(s) and settings for DBS programming will be determined based on the visualization of the electrodes in the patient-specific anatomy and the volume of tissue activated (VTA; i.e., the tissue enclosed within an iso-surface of the activation function). This will be determined with help of the software program Brainlab with the GUIDE XT module.
Threshold assessment-based programming
The preferred contact point(s) and settings for DBS programming will be determined according to current clinical practice. During the threshold assessment, the amount of electrical current needed to generate symptomatic improvement and the amount of electrical current needed to generate adverse-effects are determined for every contact point of both DBS leads by increasing current with 0.5 mA steps from 0 to approximately 5.0 mA. With each step, severity of Parkinson symptoms and presence of possible adverse-effects are assessed. For each side (i.e., left and right), the contact point with the most favorable trade-off between clinical improvement and adverse effects will be used for stimulation.
RECRUITING
Amsterdam UMC location AMC, Amsterdam
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER