Objective: To evaluate the extended long-term durability, programming stability, and safety of adaptive deep brain stimulation (aDBS) in people with Parkinson’s disease (PD).

Background: Adaptive DBS is a recently available enhancement to continuous DBS (cDBS) that dynamically adjusts stimulation amplitude based on neural signals. The durability of aDBS during extended use has not been well characterized. Long-term safety and programming data were evaluated using the complete dataset from the ADAPT-PD trial.

Method: The study status, follow-up time, and programming parameters were assessed from patients in the pivotal ADAPT-PD Trial (NCT04547712). Two modes of aDBS were evaluated: single-threshold (ST-aDBS) and dual-threshold (DT-aDBS). Extended long-term use included the Long-term Follow-up (~10 mos) and the optional Extended Access phase (varied length, ending at study closure/aDBS approval). aDBS durability was defined as the probability of staying on aDBS using the Kaplan-Meier method. Changes in stimulation limits and LFP thresholds were assessed between visits. Safety was evaluated using stimulation-related adverse events (AEs) during long-term use.

Results: Sixty patients (mean [SD] age 61 [8.2] years; 41 [68%] male) with moderate to advanced PD completed aDBS evaluation, 59 entered the long-term follow up (23 ST-aDBS, 36 DT-aDBS). Patients maintained the same aDBS mode throughout long-term use. The mean aDBS follow-up time was 31.7 mos (SD 10.57, range 3-47). aDBS durability was at 88.2% (95% CI 76.9-94.2%) through ~4 years. For ST-aDBS, upper and lower stimulation limits were unchanged in 82.0% and 81.1% of visits (n=217), respectively; the corresponding proportions for DT-aDBS were 74.2% and 79.5% (n=430). Similarly, LFP thresholds remained unchanged in 87.6% of ST-aDBS visits. In DT-aDBS, the upper and lower LFP thresholds remained unchanged in 78.8% and 79.5% of visits, respectively. Besides scheduled visits every 3 mos for the first year and then every 6 mos thereafter (per protocol), there was only one unscheduled visit every 10 mos during extended long-term use. There were 3.7 stimulation-related AEs per 100 follow-up mos.

Conclusion: Adaptive DBS demonstrated high long-term durability, stable programming parameters, and a favorable safety profile during extended use. These findings suggest that aDBS can be maintained with a reasonable programming visit cadence while supporting sustained long-term therapy in PD.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/extended-long-term-follow-up-of-adaptive-deep-brain-stimulation-in-parkinsons-disease/