PMID- 16943402
OWN - NLM
STAT- MEDLINE
DCOM- 20060905
LR  - 20231120
IS  - 1533-4406 (Electronic)
IS  - 0028-4793 (Linking)
VI  - 355
IP  - 9
DP  - 2006 Aug 31
TI  - A randomized trial of deep-brain stimulation for Parkinson's disease.
PG  - 896-908
AB  - BACKGROUND: Neurostimulation of the subthalamic nucleus reduces levodopa-related 
      motor complications in advanced Parkinson's disease. We compared this treatment 
      plus medication with medical management. METHODS: In this randomized-pairs trial, 
      we enrolled 156 patients with advanced Parkinson's disease and severe motor 
      symptoms. The primary end points were the changes from baseline to six months in 
      the quality of life, as assessed by the Parkinson's Disease Questionnaire 
      (PDQ-39), and the severity of symptoms without medication, according to the 
      Unified Parkinson's Disease Rating Scale, part III (UPDRS-III). RESULTS: Pairwise 
      comparisons showed that neurostimulation, as compared with medication alone, 
      caused greater improvements from baseline to six months in the PDQ-39 (50 of 78 
      pairs, P=0.02) and the UPDRS-III (55 of 78, P<0.001), with mean improvements of 
      9.5 and 19.6 points, respectively. Neurostimulation resulted in improvements of 
      24 to 38 percent in the PDQ-39 subscales for mobility, activities of daily 
      living, emotional well-being, stigma, and bodily discomfort. Serious adverse 
      events were more common with neurostimulation than with medication alone (13 
      percent vs. 4 percent, P<0.04) and included a fatal intracerebral hemorrhage. The 
      overall frequency of adverse events was higher in the medication group (64 
      percent vs. 50 percent, P=0.08). CONCLUSIONS: In this six-month study of patients 
      under 75 years of age with severe motor complications of Parkinson's disease, 
      neurostimulation of the subthalamic nucleus was more effective than medical 
      management alone. (ClinicalTrials.gov number, NCT00196911 [ClinicalTrials.gov].).
CI  - Copyright 2006 Massachusetts Medical Society.
FAU - Deuschl, Gunther
AU  - Deuschl G
AD  - Christian Albrechts University, Kiel, Germany. g.deuschl@neurologie.uni-kiel.de
FAU - Schade-Brittinger, Carmen
AU  - Schade-Brittinger C
FAU - Krack, Paul
AU  - Krack P
FAU - Volkmann, Jens
AU  - Volkmann J
FAU - Schafer, Helmut
AU  - Schafer H
FAU - Botzel, Kai
AU  - Botzel K
FAU - Daniels, Christine
AU  - Daniels C
FAU - Deutschlander, Angela
AU  - Deutschlander A
FAU - Dillmann, Ulrich
AU  - Dillmann U
FAU - Eisner, Wilhelm
AU  - Eisner W
FAU - Gruber, Doreen
AU  - Gruber D
FAU - Hamel, Wolfgang
AU  - Hamel W
FAU - Herzog, Jan
AU  - Herzog J
FAU - Hilker, Rudiger
AU  - Hilker R
FAU - Klebe, Stephan
AU  - Klebe S
FAU - Kloss, Manja
AU  - Kloss M
FAU - Koy, Jan
AU  - Koy J
FAU - Krause, Martin
AU  - Krause M
FAU - Kupsch, Andreas
AU  - Kupsch A
FAU - Lorenz, Delia
AU  - Lorenz D
FAU - Lorenzl, Stefan
AU  - Lorenzl S
FAU - Mehdorn, H Maximilian
AU  - Mehdorn HM
FAU - Moringlane, Jean Richard
AU  - Moringlane JR
FAU - Oertel, Wolfgang
AU  - Oertel W
FAU - Pinsker, Marcus O
AU  - Pinsker MO
FAU - Reichmann, Heinz
AU  - Reichmann H
FAU - Reuss, Alexander
AU  - Reuss A
FAU - Schneider, Gerd-Helge
AU  - Schneider GH
FAU - Schnitzler, Alfons
AU  - Schnitzler A
FAU - Steude, Ulrich
AU  - Steude U
FAU - Sturm, Volker
AU  - Sturm V
FAU - Timmermann, Lars
AU  - Timmermann L
FAU - Tronnier, Volker
AU  - Tronnier V
FAU - Trottenberg, Thomas
AU  - Trottenberg T
FAU - Wojtecki, Lars
AU  - Wojtecki L
FAU - Wolf, Elisabeth
AU  - Wolf E
FAU - Poewe, Werner
AU  - Poewe W
FAU - Voges, Jurgen
AU  - Voges J
CN  - German Parkinson Study Group, Neurostimulation Section
LA  - eng
SI  - ClinicalTrials.gov/NCT00196911
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - N Engl J Med
JT  - The New England journal of medicine
JID - 0255562
RN  - 0 (Antiparkinson Agents)
SB  - IM
EIN - N Engl J Med. 2006 Sep 21;355(12):1289
CIN - N Engl J Med. 2006 Nov 23;355(21):2256; author reply 2256. PMID: 17124028
MH  - Activities of Daily Living
MH  - Aged
MH  - Antiparkinson Agents/adverse effects/*therapeutic use
MH  - *Deep Brain Stimulation/adverse effects
MH  - Dyskinesias/etiology/therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Parkinson Disease/complications/drug therapy/*therapy
MH  - *Quality of Life
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2006/09/01 09:00
MHDA- 2006/09/06 09:00
CRDT- 2006/09/01 09:00
PHST- 2006/09/01 09:00 [pubmed]
PHST- 2006/09/06 09:00 [medline]
PHST- 2006/09/01 09:00 [entrez]
AID - 355/9/896 [pii]
AID - 10.1056/NEJMoa060281 [doi]
PST - ppublish
SO  - N Engl J Med. 2006 Aug 31;355(9):896-908. doi: 10.1056/NEJMoa060281.