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:
CreatorsEmailORCIDORCID Put Code
Volkmann, JensUNSPECIFIEDorcid.org/0000-0002-9570-593XUNSPECIFIED
Wolters, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kupsch, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller, JoergUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuehn, Andrea A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schneider, Gerd-HelgeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Poewe, WernerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hering, SaschaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eisner, WilhelmUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller, Jan-UweUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Deuschl, GuentherUNSPECIFIEDorcid.org/0000-0002-4176-9196UNSPECIFIED
Pinsker, Marcus O.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Skogseid, Inger-MarieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roeste, Geir KetilUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krause, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tronnier, VolkerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schnitzler, AlfonsUNSPECIFIEDorcid.org/0000-0002-6414-7939UNSPECIFIED
Voges, JuergenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nikkhah, GuidoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vesper, JanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Classen, JosephUNSPECIFIEDorcid.org/0000-0001-7182-6967UNSPECIFIED
Naumann, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Benecke, ReinerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
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:
KeywordsLanguage
QUALITY-OF-LIFE; CERVICAL DYSTONIA; GLOBUS-PALLIDUS; SELECTION; OUTCOMESMultiple languages
Clinical NeurologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/47807

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