DBS Imaging-based vs. Threshold Assessment-based Programming

NARecruitingINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

January 3, 2024

Primary Completion Date

December 15, 2025

Study Completion Date

March 15, 2026

Conditions
Deep Brain StimulationParkinson DiseaseImaging
Interventions
OTHER

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.

OTHER

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.

Trial Locations (1)

1105 AZ

RECRUITING

Amsterdam UMC location AMC, Amsterdam

All Listed Sponsors
lead

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER