Objective: To characterize patient preference and clinical outcomes in subjects receiving adaptive Deep Brain Stimulation (aDBS) for Parkinson’s Disease (PD).

Background: Local field potential (LFP) peaks in alpha and beta bands (8-30 Hz) can act as an aDBS control signal in PD. Currently approved in Japan, implantable neurostimulators (INS) with aDBS can adjust stimulation amplitude based on the power of a chosen LFP band. The Early Adapter 1 study (EA1) assessed tolerability of two aDBS modes: dual-threshold mode (DT), which adapts stimulation amplitude to maintain LFP power between an upper and a lower threshold, and single-threshold mode (ST), which adapts stimulation amplitude when LFP power exceeds one threshold.

Method: Prospective, open-label, observational, dual-center, post-market study in PD patients receiving DBS of the subthalamic nucleus delivered by an aDBS-capable INS (Figure 1). After initial continuous DBS (cDBS) and aDBS setup, assessments under DT and ST aDBS included tolerability as measured by Global Impression of Change (GIC), patient preference, motor symptoms (MDS-UPDRS-III) as well as generic (EQ-5D) and disease-specific (PDQ-39) health-related quality of life (QoL).

Results:

Twelve subjects with PD were enrolled (age: 66.8±7.36 years, disease duration: 12.5±4.21 years, sex: 5 women). All had bilateral, detectable LFP during cDBS (left hemisphere: 15.7±5.0 Hz, right hemisphere 17.3±5.30 Hz). The mean difference between minimum and maximum amplitude during aDBS varied by subject and mode: 0.5±0.32 mA in DT vs. 0.2±0.17 mA in ST. Using GIC compared to cDBS baseline, all subjects tolerated at least one mode of aDBS. Specifically, 33% subjects showed decided improvement, 33% slight improvement and 33% no improvement after receiving DT aDBS (Table 1), respectively 30%, 50% and 20% after receiving ST aDBS (Table 2). No patient worsened compared to cDBS baseline. Seven subjects preferred DT, 2 subjects preferred ST, 1 had no preference. ST could not be set up in two subjects. Exploratory analyses assessing the link between patient preference, QoL and motor outcomes will be presented.

Conclusion: Beyond tolerability, patient preference towards DT vs. ST aDBS mode may depend on several QoL and motor outcomes. Further research is needed to confirm these initial results and to identify predictors of outcome for aDBS modes.

References: Darcy N, Lofredi R, Al-Fatly B, et al. Spectral and spatial distribution of subthalamic beta peak activity in Parkinson’s disease patients. Exp Neurol. June 2022:114150. doi:10.1016/j.expneurol.2022.114150

Little S, Brown P. What brain signals are suitable for feedback control of deep brain stimulation in Parkinson’s disease? Ann N Y Acad Sci. 2012;1265:9-24. doi:10.1111/j.1749-6632.2012.06650.x

Nakajima A, Shimo Y, Fuse A, Tokugawa J, Hishii M, Iwamuro H, Umemura A, Hattori N. Case Report: Chronic Adaptive Deep Brain Stimulation Personalizing Therapy Based on Parkinsonian State. Front Hum Neurosci. 2021 Aug 13;15:702961. doi: 10.3389/fnhum.2021.702961.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/adaptive-deep-brain-stimulation-for-parkinsons-disease-from-tolerability-to-patient-preference-and-clinical-outcomes/