Congratulations Drs. Michael Okun and Kelly Foote on the publication of “EP013 / #143 Impact of Image -Guided Programming (IGP) on Initial DBS Clinic Visit Times and Outcomes”, which appears in the December issue of Neuromodulation: Technology at the Neural Interface.
Introduction
Historically, optimization of DBS programming consists of a lengthy trial-and-error process. This undertaking can be both time-consuming and burdensome, potentially leading to extended programming sessions and the potential need for more frequent clinical visits. The use of an IGP-based platform to visualize lead location relative to patient anatomy may be capable of reducing programming times and aiding active contact(s) selection through direct visualization and targeting of Stimulation Field Models (SFMs).
Materials / Methods
Novel IGP software (GUIDETM XT, Boston Scientific, Valencia, CA, USA) was evaluated as part of an ongoing prospective, multicenter, registry (NCT02071134) in which pre-operative MRI and post-operative CT scans were provided in order to localize the DBS lead relative to each patient’s anatomy and to select of programming parameters which are aligned with SFMs. The time to reach effective DBS settings during the initial programming session was collected, along with the device aided suggested stimulation settings. DBS stimulation settings were also collected at follow-up visits.
Results
To date, 59-patients (mean age 62.9-years, 75% male) with 10.5-years of disease have been enrolled. Initial programming of bilateral directional leads, where the IGP software was utilized, occurred at a mean of 35.6 ± 4.3 minutes, and 62% of patients completed these sessions in ≤30 minutes (70% GPi, 61% STN). A smaller cohort of eighteen patients (with 36 leads) completed study visits up to 12 months following this visit and had programming information available. A 20-point improvement (n = 14) in motor function was noted at 6 months and sustained up to 1 year (n = 8) as assessed by MDS-UPDRS III scores in the medication off stimulation on condition. Fifty percent (18 of 36) of the programs provided at the initial device activation were still being utilized at their subsequent 6- and 12-month visits.
Discussion
Preliminary results suggest the use of IGP software reduced the time required to achieve optimal therapeutic settings for bilateral STN DBS devices in daily clinical practice. Shorter, more efficient programming sessions will be potentially useful to clinicians as long as stable and efficacious DBS settings can be shown as clear outcomes. This real-world database will address these challenges.
Conclusions
These results indicate that IGP can foster shorter initial programming sessions compared with traditional trial-and-error approaches (-140 min).1 Further, IGP-suggested settings are used by patients up to 1-year with sustained motor improvement.