Universität zu Köln

Volkmann, Jens ORCID: 0000-0002-9570-593X, Wolters, Alexander, Kupsch, Andreas, Mueller, Joerg, Kuehn, Andrea A., Schneider, Gerd-Helge, Poewe, Werner, Hering, Sascha, Eisner, Wilhelm, Mueller, Jan-Uwe, Deuschl, Guenther ORCID: 0000-0002-4176-9196, Pinsker, Marcus O., Skogseid, Inger-Marie, Roeste, Geir Ketil, Krause, Martin, Tronnier, Volker, Schnitzler, Alfons ORCID: 0000-0002-6414-7939, Voges, Juergen, Nikkhah, Guido, Vesper, Jan, Classen, Joseph ORCID: 0000-0001-7182-6967, Naumann, Markus and Benecke, Reiner (2012). Pallidal deep brain stimulation in patients with primary generalised or segmental dystonia: 5-year follow-up of a randomised trial. Lancet Neurol., 11 (12). S. 1029 - 1039. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1474-4422

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Abstract

Background Severe forms of primary dystonia are difficult to manage medically. We assessed the safety and efficacy of pallidal neurostimulation in patients with primary generalised or segmental dystonia prospectively followed up for 5 years in a controlled multicentre trial. Methods In the parent trial, 40 patients were randomly assigned to either sham neurostimulation or neurostimulation of the internal globus pallidus for a period of 3 months and thereafter all patients completed 6 months of active neurostimulation. 38 patients agreed to be followed up annually after the activation of neurostimulation, including assessments of dystonia severity, pain, disability, and quality of life. The primary endpoint of the 5-year follow-up study extension was the change in dystonia severity at 3 years and 5 years as assessed by open-label ratings of the Burke-Fahn-Marsden dystonia rating scale (BFMDRS) motor score compared with the preoperative baseline and the 6-month visit. The primary endpoint was analysed on an intention-to-treat basis. The original trial is registered with ClinicalTrials.gov (NCT00142259). Findings An intention-to-treat analysis including all patients from the parent trial showed significant improvements in dystonia severity at 3 years and 5 years compared with baseline, which corresponded to -20.8 points (SD 17.1; -47.9%; n=40) at 6 months; -26.5 points (19-7; -61.1%; n=31) at 3 years; and -25.1 points (21.3; -57.8%; n=32). The improvement from 6 months to 3 years (-5.7 points [SD 8.4]; 34%) was significant and sustained at the 5-year follow-up (-4.3 [10.4]). 49 new adverse events occurred between 6 months and 5 years. Dysarthria and transient worsening of dystonia were the most common non-serious adverse events. 21 adverse events were rated serious and were almost exclusively device related. One patient attempted suicide shortly after the 6-month visit during a depressive episode. All serious adverse events resolved without permanent sequelae. Interpretation 3 years and 5 years after surgery, pallidal neurostimulation continues to be an effective and relatively safe treatment option for patients with severe idiopathic dystonia. This long-term observation provides further evidence in favour of pallidal neurostimulation as a first-line treatment for patients with medically intractable, segmental, or generalised dystonia.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Volkmann, Jens UNSPECIFIED orcid.org/0000-0002-9570-593X UNSPECIFIED Wolters, Alexander UNSPECIFIED UNSPECIFIED UNSPECIFIED Kupsch, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, Joerg UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuehn, Andrea A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schneider, Gerd-Helge UNSPECIFIED UNSPECIFIED UNSPECIFIED Poewe, Werner UNSPECIFIED UNSPECIFIED UNSPECIFIED Hering, Sascha UNSPECIFIED UNSPECIFIED UNSPECIFIED Eisner, Wilhelm UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, Jan-Uwe UNSPECIFIED UNSPECIFIED UNSPECIFIED Deuschl, Guenther UNSPECIFIED orcid.org/0000-0002-4176-9196 UNSPECIFIED Pinsker, Marcus O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Skogseid, Inger-Marie UNSPECIFIED UNSPECIFIED UNSPECIFIED Roeste, Geir Ketil UNSPECIFIED UNSPECIFIED UNSPECIFIED Krause, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Tronnier, Volker UNSPECIFIED UNSPECIFIED UNSPECIFIED Schnitzler, Alfons UNSPECIFIED orcid.org/0000-0002-6414-7939 UNSPECIFIED Voges, Juergen UNSPECIFIED UNSPECIFIED UNSPECIFIED Nikkhah, Guido UNSPECIFIED UNSPECIFIED UNSPECIFIED Vesper, Jan UNSPECIFIED UNSPECIFIED UNSPECIFIED Classen, Joseph UNSPECIFIED orcid.org/0000-0001-7182-6967 UNSPECIFIED Naumann, Markus UNSPECIFIED UNSPECIFIED UNSPECIFIED Benecke, Reiner UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-478074
DOI:	10.1016/S1474-4422(12)70257-0
Journal or Publication Title:	Lancet Neurol.
Volume:	11
Number:	12
Page Range:	S. 1029 - 1039
Date:	2012
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1474-4422
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language QUALITY-OF-LIFE; CERVICAL DYSTONIA; GLOBUS-PALLIDUS; SELECTION; OUTCOMES Multiple languages Clinical Neurology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/47807