New England Journal of Medicine [2013] 368 (7) : 610-622
(Schuepbach WM, Rau J, Knudsen K, Volkmann J, Krack P, Timmermann L, Hälbig TD,
Hesekamp H, Navarro SM, Meier N, Falk D, Mehdorn M, Paschen S, Maarouf M, Barbe
MT, Fink GR, Kupsch A, Gruber D, Schneider GH, Seigneuret E, Kistner A, Chaynes
P, Ory-Magne F, Brefel Courbon C, Vesper J, Schnitzler A, Wojtecki L, Houeto JL,
Bataille B, Maltête D, Damier P, Raoul S, Sixel-Doering F, Hellwig D, Gharabaghi
A, Krüger R, Pinsker MO, Amtage F, Régis JM, Witjas T, Thobois S, Mertens P,
Kloss M, Hartmann A, Oertel WH, Post B, Speelman H, Agid Y, Schade-Brittinger C,
Deuschl G; EARLYSTIM Study Group)
Researchers assessed
whether it would be suitable to use Subthalamic stimulation at an earlier stage
of Parkinson's Disease. Subthalamic stimulation, which is referred to as DBS
(Deep Brain Stimulation), involves the use of
electrodes that are implanted into the brain and connected to a small electrical
device called a pulse generator that can be externally programmed. DBS can
reduce the need for L-dopa and related drugs, which in turn decreases the
involuntary movements called dyskinesias that are a common side effect of
L-dopa.
Researchers assessed
whether it would be suitable to use Subthalamic stimulation at an earlier stage
of Parkinson's Disease. Subthalamic stimulation, which is referred to as DBS
(Deep Brain Stimulation), involves the use of
electrodes that are implanted into the brain and connected to a small electrical
device called a pulse generator that can be externally programmed. DBS can
reduce the need for L-dopa and related drugs, which in turn decreases the
involuntary movements called dyskinesias that are a common side effect of
L-dopa.
In a two year clinical trial people with Parkinson's Disease
and early motor complications (with an average age of 52 and a mean duration of
Parkinson's Disease of 7.5 years) underwent neurostimulation plus medical
therapy or only medical therapy alone. The primary end point was quality of
life, as assessed with the use of the Parkinson's Disease Questionnaire (PDQ-39)
with scores ranging from 0 to 100 and higher scores indicating worse function.
For the primary outcome of quality of life, the mean score for
the neurostimulation group improved by 7.8 points, and that for the
medical-therapy group worsened by 0.2 points. Neurostimulation was superior to
medical therapy with respect to motor disability, activities of daily living,
L-dopa induced motor complications, and time with good mobility and no
dyskinesia. Serious adverse events occurred in 54% of the people in the
neurostimulation group and in 44% of those in the medical therapy group. Serious
adverse events related to surgical implantation or the neurostimulation device
occurred in 17% of people.
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