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Randomized Controlled Trial
. 2018 Jan;33(1):165-169.
doi: 10.1002/mds.27238. Epub 2017 Nov 22.

Pulse duration settings in subthalamic stimulation for Parkinson's disease

Frank Steigerwald  1 , Lars Timmermann  2 , Andrea Kühn  3 , Alfons Schnitzler  4 , Martin M Reich  1 , Anna Dalal Kirsch  1 , Michael Thomas Barbe  2 , Veerle Visser-Vandewalle  2 , Julius Hübl  3 , Christoph van Riesen  3 , Stefan Jun Groiss  4 , Alexia-Sabine Moldovan  4 , Sherry Lin  5 , Stephen Carcieri  5 , Ljubomir Manola  6 , Jens Volkmann  1
Affiliations
Randomized Controlled Trial

Pulse duration settings in subthalamic stimulation for Parkinson's disease

Frank Steigerwald et al. Mov Disord. 2018 Jan.

Abstract

Background: Stimulation parameters in deep brain stimulation (DBS) of the subthalamic nucleus for Parkinson's disease (PD) are rarely tested in double-blind conditions. Evidence-based recommendations on optimal stimulator settings are needed. Results from the CUSTOM-DBS study are reported, comparing 2 pulse durations.

Methods: A total of 15 patients were programmed using a pulse width of 30 µs (test) or 60 µs (control). Efficacy and side-effect thresholds and unified PD rating scale (UPDRS) III were measured in meds-off (primary outcome). The therapeutic window was the difference between patients' efficacy and side effect thresholds.

Results: The therapeutic window was significantly larger at 30 µs than 60 µs (P = ·0009) and the efficacy (UPDRS III score) was noninferior (P = .00008).

Interpretation: Subthalamic neurostimulation at 30 µs versus 60 µs pulse width is equally effective on PD motor signs, is more energy efficient, and has less likelihood of stimulation-related side effects. © 2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

Keywords: Deep brain stimulation; Parkinson's disease; pulse width; stimulation parameters; subthalamic.

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Figures

Figure 1
Figure 1
Schematic of the CUSTOM‐DBS study, a multicenter, double‐blind, randomized controlled trial. At the programming visit, the therapeutic window was first measured in a randomized, double‐blind assessment at four different program settings. Double‐blind UPDRS III and exploratory quantitative assessments (Kinesia assessments of rest tremor, finger tapping, and rapidly alternating movement tasks; Kinesia ProView, Great Lakes Neurotechnologies) were then taken at the efficacy threshold for rigidity for each setting. In addition to test and control pulse width settings, current steering settings were also tested as exploratory endpoints. Stimulation was activated on the best therapeutic contact as identified by clinical practice and programmed according to the figure. [Color figure can be viewed at wileyonlinelibrary.com]
Figure 2
Figure 2
Coprimary endpoints. (A) Superiority of the therapeutic window size (left) and noninferiority of UPDRS III (right) at a short‐pulse width. Error bars represent ± 1 standard error. (B) Side effect observed at threshold during the therapeutic measurement. The most common side effects were dysarthria and muscle twitch related to pyramidal tract activation. [Color figure can be viewed at wileyonlinelibrary.com]
See this image and copyright information in PMC

Comment in

  • Next generation programming.
    Israel Z, Bergman H, Eitan R. Israel Z, et al. Mov Disord. 2018 Feb;33(2):186. doi: 10.1002/mds.27322. Epub 2018 Jan 25. Mov Disord. 2018. PMID: 29369418 No abstract available.

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