Document Detail


Pallidal deep brain stimulation in patients with primary generalised or segmental dystonia: 5-year follow-up of a randomised trial.
MedLine Citation:
PMID:  23123071     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
FUNDING: Medtronic.
Authors:
Jens Volkmann; Alexander Wolters; Andreas Kupsch; Jörg Müller; Andrea A Kühn; Gerd-Helge Schneider; Werner Poewe; Sascha Hering; Wilhelm Eisner; Jan-Uwe Müller; Günther Deuschl; Marcus O Pinsker; Inger-Marie Skogseid; Geir Ketil Roeste; Martin Krause; Volker Tronnier; Alfons Schnitzler; Jürgen Voges; Guido Nikkhah; Jan Vesper; Joseph Classen; Markus Naumann; Reiner Benecke;
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-11-01
Journal Detail:
Title:  The Lancet. Neurology     Volume:  11     ISSN:  1474-4465     ISO Abbreviation:  Lancet Neurol     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-11-16     Completed Date:  2013-01-18     Revised Date:  2014-08-15    
Medline Journal Info:
Nlm Unique ID:  101139309     Medline TA:  Lancet Neurol     Country:  England    
Other Details:
Languages:  eng     Pagination:  1029-38     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Elsevier Ltd. All rights reserved.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00142259
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MeSH Terms
Descriptor/Qualifier:
Adult
Deep Brain Stimulation / methods*,  trends*
Dystonic Disorders / physiopathology*,  therapy*
Female
Follow-Up Studies
Globus Pallidus / physiology*
Humans
Male
Middle Aged
Prospective Studies
Treatment Outcome
Young Adult
Investigator
Investigator/Affiliation:
R Benecke / ; J Volkmann / ; Lothar Gierl / ; Lothar Gierl / ; R Benecke / ; G Deuschl / ; J Müller / ; M O Pinsker / ; W Poewe / ; J Volkmann / ; A Wolters / ; M H Mehdorn / ; Doreen Gruber / ; Anatol Kivi / ; Andrea A Kühn / ; Andreas Kupsch / ; Bianca Müller / ; Gerd-Helge Schneider / ; Thomas Trottenberg / ; Alfons Schnitzler / ; Volker Sturm / ; Lars Timmermann / ; Jürgen Voges / ; Lars Wojtecki / ; Guido Nikkah / ; Markus Pinsker / ; Thomas Prokop / ; Jan Vesper / ; Manja Kloss / ; Martin Krause / ; Wilhelm Eisner / ; Thomas Fiegele / ; Jürg Müller / ; Sasha Hering / ; Werner Poewe / ; Günther Deuschl / ; Jan Herzog / ; Maximilian M Mehdorn / ; Marcus O Pinsker / ; Monika Pötter / ; Frank Steigerwald / ; Jens Volkmann / ; Hans-Werner Boothe / ; Angela Brentrup / ; Juliane Vollmer-Haase / ; Geir Ketil Roeste / ; Inger Marie Skogseid / ; Reiner Benecke / ; Jan-Uwe Müller / ; Matthias Wittstock / ; Alexander Wolters / ; Joseph Classen / ; Markus Naumann / ; Alex Schramm /
Comments/Corrections
Comment In:
Lancet Neurol. 2012 Dec;11(12):1014-5   [PMID:  23123072 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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