Objective: We describe assessment of Parkinson’s disease (PD) patient outcomes using an image-guided programming (IGP) tool as conducted during initial Deep Brain Stimulation (DBS) programming, either with STN or GPi as brain target.

Background: Optimization of DBS programming can be a lengthy, empirical trial-and-error process potentially leading to extended programming sessions and frequent visits. An IGP-based platform can help visualize lead location relative to anatomy with capability of reducing programming times and aiding active contact(s) selection through direct visualization and targeting of Stimulation Field Models (SFMs).

Method: Novel IGP software (GUIDE XT, Boston Scientific) was evaluated from an ongoing prospective, multicenter, registry (NCT02071134) in which pre-operative MRI and post-operative CT scans were provided to localize the DBS lead relative to each subject’s anatomy and to select programming parameters per alignment with SFMs. Time to reach effective DBS settings during the initial programming session was collected, along with device-aided suggested stimulation settings.

Results: To date, 57-subjects (mean age 62.9-years, 77% male) with 10.1-years of disease have enrolled. Initial programming sessions (post-implant), where IGP provided settings for directional leads, lasted 39.4±4.4 minutes (mean ± SE). Fifty-five percent (31/56) completed initial programming of bilateral directional leads with IGP in <30-minutes. Motor function (mean MDS-UPDRS Ill scores [Meds OFF]) was significantly improved by 55% (n=45) and 45% (n=37) at 6-and 12-months, respectively. Of 21-patients for whom follow-up programming information out to 6- and 12-months was available, 52% and 43% of DBS programs remained unchanged from initial setting (i.e., no change in active contact(s) and cathodic/anodic distribution of current), respectively, as suggested by IGP.

Conclusion: Results obtained in this analysis indicate that use of IGP led to shorter initial programming sessions (39.4 min, n = 56) compared to a traditional trial-and-error approach (~140 min) as reported in the literature [1].  These quicker, more efficient initial programming sessions utilizing IGP-suggested settings were observed to be associated with sustained and clinically significant motor improvement. However, further studies are needed to compare IGP to traditional programming methods.

References: 1. Pavese N, et al. World Neurosurg. 2020 Feb;134:e98-e102.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/assessment-of-image-guided-programming-igp-in-bilateral-stn-and-gpi-deep-brain-stimulation-on-programming-time-and-setting-outcomes/