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Background Neurostimulation 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.
Methods Forty 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.
Results Three 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.
Conclusions Bilateral 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]
.)
Source Information
From Charité Universitätsmedizin Berlin, Campus Virchow, Berlin (A.K., T.T., G.-H.S.); University of Rostock, Rostock (R.B., A.W.); Ernst Moritz Arndt University, Greifswald (J.-U.M.); Christian Albrechts University, Kiel (G.D., M.O.P., J. Volkmann); University of Münster, Münster (J.V.-H., A.B.); University of Heidelberg, Heidelberg (M.K., V.T.); Heinrich Heine University, Düsseldorf (A.S.); University of Cologne, Cologne (J. Voges); University of Freiburg, Freiburg (G.N., J. Vesper); and University of Würzburg, Würzburg (M.N.) — all in Germany; Medical University Innsbruck, Innsbruck, Austria (J.M., W.P., W.E.); and University of Oslo, Oslo (I.M.S., G.K.R.).
Address reprint requests to Dr. Volkmann at the Department of Neurology, Christian Albrechts University, Schittenhelmstr. 10, D-24105 Kiel, Germany, or at j.volkmann{at}neurologie.uni-kiel.de.
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