Deep brain stimulation of the posterior subthalamic area and the thalamus in patients with essential tremor: study protocol for a randomized controlled pilot trial.
BACKGROUND
Deep 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
A 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.


CONCLUSIONS
The 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.


BACKGROUND
German Clinical Trials Register: DRKS00004235 . Registered on 4 July 2012.
Department of Neurology, University Hospital Cologne, Kerpener Str. 62, 50937, Cologne, Germany. michael.barbe@uk-koeln.de.|Cognitive Neuroscience (INM3), Institute of Neuroscience and Medicine, Research Centre Jülich, Jülich, Germany. michael.barbe@uk-koeln.de.
Michael T
MT
Barbe
Institute of Medical Statistics, Informatics and Epidemiology, University Cologne, Cologne, Germany.
Jeremy
J
Franklin
Clinical Trials Centre Cologne, Cologne, Germany.
Daria
D
Kraus
Department of Neurology, University Hospital Cologne, Kerpener Str. 62, 50937, Cologne, Germany.
Paul
P
Reker
Department of Neurology, University Hospital Cologne, Kerpener Str. 62, 50937, Cologne, Germany.
Till A
TA
Dembek
Rehabilitation Center Godeshoehe, Bonn, Germany.
Niels
N
Allert
Department of Stereotactic and Functional Neurosurgery, University Hospital Cologne, Kerpener Str. 62, D-50937, Cologne, Germany.
Jochen
J
Wirths
Department of Stereotactic Neurosurgery, University Hospital Magdeburg, Magdeburg, Germany.|Leibniz Institute for Neurobiology (LIN), Magdeburg, Germany.
Jürgen
J
Voges
Department of Neurology, University Hospital Cologne, Kerpener Str. 62, 50937, Cologne, Germany.
Lars
L
Timmermann
Department of Stereotactic and Functional Neurosurgery, University Hospital Cologne, Kerpener Str. 62, D-50937, Cologne, Germany. veerle.visser-vandewalle@uk-koeln.de.
Veerle
V
Visser-Vandewalle
Constant current stimulation; Crossover study; Deep brain stimulation (DBS); Essential tremor (ET); Posterior subthalamic nucleus (PSA); Stimulation-induced side effects; Ventral intermediate nucleus of the thalamus (VIM); Zona incerta (Zi)
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