Objectives
Evidence suggests that non-conventional programming may improve deep brain
stimulation (DBS) therapy for movement disorders. The primary objective was to assess
feasibility of testing the tolerability of several non-conventional settings in
Parkinson’s disease (PD) and essential tremor (ET) subjects in a single office
visit. Secondary objectives were to explore for potential efficacy signals and to assess
the energy demand on the implantable pulse-generators (IPG).
Materials and Methods
A custom firmware (FW) application was developed and acutely uploaded to the
IPGs of 8 PD and 3 ET subjects, allowing delivery of several non-conventional DBS
settings, including narrow pulse widths, square biphasic pulses and irregular pulse
patterns. Standard clinical rating scales and several objective measures were used to
compare motor outcomes with sham, clinically-optimal and non-conventional settings.
Blinded and randomized testing was conducted in a traditional office setting.
Results
Overall, the non-conventional settings were well tolerated. Under these
conditions it was also possible to detect clinically-relevant differences in DBS
responses using clinical rating scales but not objective measures. Compared to the
clinically-optimal settings, some non-conventional settings appeared to offer similar
benefit (e.g. narrow pulse widths) and others lesser benefit. Moreover, the results
suggest that square biphasic pulses may deliver greater benefit. No unexpected IPG
efficiency disadvantages were associated with delivering non-conventional settings.
Conclusions
It is feasible to acutely screen non-conventional DBS settings using controlled
study designs in traditional office settings. Simple IPG FW upgrades may provide more
DBS programming options for optimizing therapy. Potential advantages of narrow and
biphasic pulses deserve follow up.
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