• Andreas Kupsch, Reiner Benecke, Jörg Müller, Thomas Trottenberg, Gerd-Helge Schneider, Werner Poewe, Wilhelm Eisner, Alexander Wolters, Jan-Uwe Müller, Günther Deuschl, Marcus O Pinsker, Inger Marie Skogseid, Geir Ketil Roeste, Juliane Vollmer-Haase, Angela Brentrup, Martin Krause, Volker Tronnier, Alfons Schnitzler, Jürgen Voges, Guido Nikkhah, Jan Vesper, Markus Naumann, Jens Volkmann, and Deep-Brain Stimulation for Dystonia Study Group.
• Charité Universitätsmedizin Berlin, Campus Virchow, Berlin, Germany.
• N. Engl. J. Med. 2006 Nov 9;355(19):1978-90.

BackgroundNeurostimulation of the internal globus pallidus has been shown to be effective in reducing symptoms of primary dystonia. We compared this surgical treatment with sham stimulation in a randomized, controlled clinical trial.MethodsForty patients with primary segmental or generalized dystonia received an implanted device for deep-brain stimulation and were randomly assigned to receive either neurostimulation or sham stimulation for 3 months. The primary end point was the change from baseline to 3 months in the severity of symptoms, according to the movement subscore on the Burke-Fahn-Marsden Dystonia Rating Scale (range, 0 to 120, with higher scores indicating greater impairment). Two investigators who were unaware of treatment status assessed the severity of dystonia by reviewing videotaped sessions. Subsequently, all patients received open-label neurostimulation; blinded assessment was repeated after 6 months of active treatment.ResultsThree months after randomization, the change from baseline in the mean (+/-SD) movement score was significantly greater in the neurostimulation group (-15.8+/-14.1 points) than in the sham-stimulation group (-1.4+/-3.8 points, P<0.001). During the open-label extension period, this improvement was sustained among patients originally assigned to the neurostimulation group, and patients in the sham-stimulation group had a similar benefit when they switched to active treatment. The combined analysis of the entire cohort after 6 months of neurostimulation revealed substantial improvement in all movement symptoms (except speech and swallowing), the level of disability, and quality of life, as compared with baseline scores. A total of 22 adverse events occurred in 19 patients, including 4 infections at the stimulator site and 1 lead dislodgment. The most frequent adverse event was dysarthria.ConclusionsBilateral pallidal neurostimulation for 3 months was more effective than sham stimulation in patients with primary generalized or segmental dystonia. (ClinicalTrials.gov number, NCT00142259 [ClinicalTrials.gov].).Copyright 2006 Massachusetts Medical Society.

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