title: Pallidal deep-brain stimulation in primary generalized or segmental dystonia.
abstract: 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].).
authors.affiliation: Charité Universitätsmedizin Berlin, Campus Virchow, Berlin, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Kupsch
authors.forename: Reiner
authors.initials: R
authors.lastname: Benecke
authors.forename: Jörg
authors.initials: J
authors.lastname: Müller
authors.forename: Thomas
authors.initials: T
authors.lastname: Trottenberg
authors.forename: Gerd-Helge
authors.initials: GH
authors.lastname: Schneider
authors.forename: Werner
authors.initials: W
authors.lastname: Poewe
authors.forename: Wilhelm
authors.initials: W
authors.lastname: Eisner
authors.forename: Alexander
authors.initials: A
authors.lastname: Wolters
authors.forename: Jan-Uwe
authors.initials: JU
authors.lastname: Müller
authors.forename: Günther
authors.initials: G
authors.lastname: Deuschl
authors.forename: Marcus O
authors.initials: MO
authors.lastname: Pinsker
authors.forename: Inger Marie
authors.initials: IM
authors.lastname: Skogseid
authors.forename: Geir Ketil
authors.initials: GK
authors.lastname: Roeste
authors.forename: Juliane
authors.initials: J
authors.lastname: Vollmer-Haase
authors.forename: Angela
authors.initials: A
authors.lastname: Brentrup
authors.forename: Martin
authors.initials: M
authors.lastname: Krause
authors.forename: Volker
authors.initials: V
authors.lastname: Tronnier
authors.forename: Alfons
authors.initials: A
authors.lastname: Schnitzler
authors.forename: Jürgen
authors.initials: J
authors.lastname: Voges
authors.forename: Guido
authors.initials: G
authors.lastname: Nikkhah
authors.forename: Jan
authors.initials: J
authors.lastname: Vesper
authors.forename: Markus
authors.initials: M
authors.lastname: Naumann
authors.forename: Jens
authors.initials: J
authors.lastname: Volkmann
mesh_terms: D000328:Adult; D046690:Deep Brain Stimulation / Q000009:adverse effects; D004311:Double-Blind Method; D020821:Dystonic Disorders / Q000145:classification / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D005917:Globus Pallidus; D006801:Humans; D008297:Male; D012720:Severity of Illness Index