Abstract
BackgroundDeep brain stimulation (DBS) of the ventral intermediate nucleus (VIM) of the thalamus is effective in medication refractory essential tremor (ET). In recent years, evidence has accumulated that the region ventral to the VIM, the posterior subthalamic area (PSA), might be an equally or even more effective target for electrode implantation. However, this evidence is primarily based on case series, cross-sectional observations, and retrospective data.Methods/designA prospective crossover pilot study investigating the effects of PSA stimulation in medication refractory ET patients was designed. In this study, bilateral electrodes are implanted such that at least one of the electrode contacts is located in the PSA and VIM, respectively. This implantation approach allows (1) a prospective double-blind investigation of the effects of PSA stimulation compared to baseline, as well as (2) a crossover comparison between VIM and PSA stimulation with respect to tremor suppression and side effect profiles.DiscussionThe results of this double-blinded, prospective study will allow a better understanding of the effects and side effects of PSA compared to VIM-DBS in patients with ET.Trial registrationGerman Clinical Trials Register: DRKS00004235. Registered on 4 July 2012.
Highlights
Deep brain stimulation (DBS) of the ventral intermediate nucleus (VIM) of the thalamus is effective in medication refractory essential tremor (ET)
Results on posterior subthalamic area (PSA) versus VIM stimulation are conflicting, and it is unclear whether the higher efficacy of PSA stimulation compared to VIM stimulation is sustained in the clinical setting when the amount of current and the amount and severity of stimulation-induced side effects might vary between the two target areas
The higher efficacy of PSA stimulation over VIM stimulation might potentially be neutralized by the use of stronger current in the VIM group or more frequent side effects in the PSA group, the latter limiting acceptable program settings in that target area
Summary
This study investigates the effects and side effects of deep brain stimulation of the PSA and — with the help of the randomized crossover — contrasts the outcome with that of VIM stimulation This monocentric study will primarily serve as a pilot study for a larger, multicentric trial, we expect direct findings to improve treatment of future patients with ET, e.g., through a better understanding of the side effect profiles of the two target areas. It is commonly accepted that, due to the direct and strong effect of VIMDBS in ET patients, a truly blinded analysis of the preoperative to the postoperative state is probably impossible [2] To circumvent this bias, we have designed a doubleblinded analysis for the crossover trial comparing VIM and PSA, videotaping the preoperative and postoperative tremor scores for blinded analysis by an independent rater.
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