Evaluation of a Visual-Analog Scale (VAS) for Remote DBS Programming (The REMOTE-Trial)

Introduction: Deep brain stimulation (DBS) represents the treatment of choice for advanced stages of Parkinson's disease (PD). In addition to careful patient selection and precise lead placement, postoperative programming of DBS devices is considered the most important factor for the individual patient. Despite expert-based recommendations for adjusting neurostimulation parameters, DBS programming remains time- and resource-consuming, thus impacting the postoperative treatment in particular for patients without easy access to specialist care. Currently, adaptive closed-loop stimulation systems that apply disease-specific biomarkers, such as local field potentials (LFPs), are being actively examined to facilitate programming. However, the most suitable feedback signal, still remains largely unknown. We previously tested the usefulness of the patient's subjective rating on a visual analogue scale (VAS) as a potential feedback signal for DBS adjustment and found no significant difference compared to standard programming1. Our results thus suggest that DBS patients are well able to adjust their IPG setting by themselves and will support the investigation of the patient's subjective perception as a valid and useful feedback signal for DBS programming. One of the practical advantages of using VAS-based programming strategies – in addition to saving time – is the principal applicability of such an approach to a remote programming setting, although a validation of such an approach is required.

Patients & Methods: Within the scope of a prospective, randomized multicenter clinical trial (the REMOTE Trial), we will examine the effectiveness and safety of VAS-based remote DBS programming in PD by using a novel and recently introduced software platform (Abbott NeurosphereTM Virtual Clinic) that allows for the programming through a smartphone-based video connection with the patient. Therefore, n = 50 PD patients undergoing STN-DBS surgery will be randomized and subsequent to surgery will have their IPG settings adjusted either during regular visits at the hospital or alternatively be programmed remotely through a VAS-based approach.

Expected Results: Prior to surgery and after a 90 days follow-up period, we will assess specific clinical (MDS-UPDRS, PDQ-39, BDI, MOCA) parameters to determine the effectivity and safety of the two different strategies on the patient outcome and to correlate it with VAS ratings and MRI data (Fig. 1).

Conclusion: Our results will support the examination of remote-based DBS programming and evaluate the patient’s subjective judgment as a valid feedback signal.

References

1. Palleis, C., Gehmeyr, M., Mehrkens, J. H., Bötzel, K. & Koeglsperger, T. Establishment of a Visual Analog Scale for DBS Programming (VISUAL-STIM Trial). Front Neurol 11, 561323 (2020).

Fig. 1. Schematic illustrating the REMOTE Trial study protocol.

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