Background
Deep brain stimulation (DBS) electrode placement using interventional MRI has been previously reported using a commercially available skull mounted aiming device (Medtronic Nexframe MR) and native MRI scanner software. This first-generation method has technical limitations that are inherent to the hardware and software used. A novel system (SurgiVision ClearPoint) consisting of an aiming device (SMARTFrame) and software has been developed specifically for iMRI interventions including DBS.
Objective
A series of phantom and cadaver tests were performed to determine the system’s capability, preliminary accuracy and workflow.
Methods
18 experiments using a water phantom were used to determine predictive accuracy of the software. 16 experiments using a gelatin-filled skull phantom were used to determine targeting accuracy of the aiming device. 6 procedures in three cadaver heads were performed to compare workflow and accuracy of ClearPoint with Nexframe MR.
Results
Software prediction experiments showed an average error of 0.9±0.5 mm in magnitude in pitch and roll (mean pitch error −0.2±0.7 mm, mean roll error +0.2±0.7 mm) and an average error of 0.7±0.3 mm in X-Y translation with a slight anterior (0.5±0.3 mm) and lateral (0.4±0.3mm) bias. Targeting accuracy experiments showed average radial error of 0.5±0.3 mm. Cadaver experiments showed a radial error of 0.2±0.1 mm with the ClearPoint system (average procedure time 88±14 minutes) vs 0.6±0.2 mm with the Nexframe MR (average procedure time 92±12 minutes).
Conclusion
This novel system provides the submillimetric accuracy required for stereotactic interventions including DBS placement. It also overcomes technical limitations inherent in the first-generation iMRI system.
jacent tracts, and no signs of unexpected tissue damage were observed. Conclusions: This integrated delivery platform allows real-time convection-enhanced delivery to be performed with a high level of precision, predictability and safety. This approach may improve the success rate for clinical trials involving intracerebral drug delivery by direct infusion.
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