A randomized trial of deep-brain stimulation for Parkinson's disease.
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].).
Deuschl
Günther
G
Christian Albrechts University, Kiel, Germany. g.deuschl@neurologie.uni-kiel.de
Schade-Brittinger
Carmen
C
Krack
Paul
P
Volkmann
Jens
J
Schäfer
Helmut
H
Bötzel
Kai
K
Daniels
Christine
C
Deutschländer
Angela
A
Dillmann
Ulrich
U
Eisner
Wilhelm
W
Gruber
Doreen
D
Hamel
Wolfgang
W
Herzog
Jan
J
Hilker
Rüdiger
R
Klebe
Stephan
S
Kloss
Manja
M
Koy
Jan
J
Krause
Martin
M
Kupsch
Andreas
A
Lorenz
Delia
D
Lorenzl
Stefan
S
Mehdorn
H Maximilian
HM
Moringlane
Jean Richard
JR
Oertel
Wolfgang
W
Pinsker
Marcus O
MO
Reichmann
Heinz
H
Reuss
Alexander
A
Schneider
Gerd-Helge
GH
Schnitzler
Alfons
A
Steude
Ulrich
U
Sturm
Volker
V
Timmermann
Lars
L
Tronnier
Volker
V
Trottenberg
Thomas
T
Wojtecki
Lars
L
Wolf
Elisabeth
E
Poewe
Werner
W
Voges
Jürgen
J
D000203:Activities of Daily Living; D000368:Aged; D000978:Antiparkinson Agents / Q000009:adverse effects / Q000627:therapeutic use*; D046690:Deep Brain Stimulation / Q000009:adverse effects; D020820:Dyskinesias / Q000209:etiology / Q000628:therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000150:complications / Q000188:drug therapy / Q000628:therapy*; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000978:Antiparkinson Agents