IEEE Technology and Society Magazine - June 2015 - 65
W
hat should a patient know
before he or she allows a
physician to control a part
of the patient's brain?
While this sounds like a philosophical thought experiment
designed to twist the intuition,
it is meant to address the ramifications of a widely used
clinical therapy called deep brain stimulation (DBS).
Deep brain stimulation is a therapy, approved by the
Food and Drug Administration (FDA), to relieve the symptoms of movement disorders, specifically dystonia [1],
essential tremor [2], and the effects of Parkinson disease
[3], and is currently being studied for a wide variety of
psychiatric illnesses [4]. DBS is complicated to employ,
requiring the coordinated effort of a team of health care
professionals, chiefly a neurosurgeon, a neurologist, and
a neuropsychologist.
The neurosurgeon's main task is to identify the
malfunctioning brain structure, implant electrodes
in that part of the brain, confirm that the electrodes
are in the correct location, and attach them to a pulse
generator that is implanted under the skin of the
patient's chest. The neurologist evaluates the patient
prior to the surgery to determine whether or not the
patient meets the necessary criteria for treatment with
DBS and multiple times after the surgery to program
the pulse generator in order to minimize side effects
and to ensure the best therapeutic outcome for the
patient. The neuropsychologist's final task is to evaluate the patient's cognition and mood before the procedure to screen patients who have a higher probability
of being adversely effected by DBS.
During the planning stage, the patient is counseled
about what to expect from DBS, including the risks of
an adverse event, along with the probability of a positive
outcome. This process, termed "informed consent," is a
standard feature of all surgical procedures. The purpose
of informed consent is primarily to set the patient's expectations so that he or she does not unrealistically anticipate
a miraculous outcome nor does he or she overly minimize
possible complications. The patient can, therefore, rationally weigh the benefits and risks and decide whether or
not he or she wishes to have the procedure.
For some medical interventions, there are detailed
published recommendations for informed consent
forms. (For example, see [5] for a discussion about
forms for clinical trials.) For DBS, there are no guidelines
from either manufactures or professional organizations
setting forth exactly what information is necessary and
sufficient for an informed consent. Therefore, currently,
neurosurgeons are left to use their judgment as to what
information they believe is necessary for the patient to
make an informed decision on whether to treat or not.
june 2015
∕
As an example, Dr. Thomas Witt, an associate professor of neurosurgery at Indiana University School of Medicine who routinely performs DBS operations, describes
his approach to informed consent as follows:
For me, I always first discuss the general risks of
any surgical procedure: bleeding, infection, and
anesthesia. Then the specific risks: failure to accomplish the goal of the procedure (e.g., symptoms may
not go away completely or satisfactorily), risks of
temporary or permanent decrease in brain function
that depends on what part of the brain is being operated on, and things that are common to any brain
surgery such as CSF leak, seizures, and the potential
for severe permanent brain injury from hemorrhage
or stroke that could lead to problems as severe as
paralysis, aphasia, not waking up. When a device like
DBS is involved, I discuss risks of mechanical or
electrical failure of a man-made device, need for generator replacement, and the potential need to revise
the position of the electrode due to suboptimal position. Within the realm of changes in brain function
mentioned above, I tell them that the potential for
the most severe change in brain function is from a
hemorrhage, but that people could have a new problem with brain function unrelated to a hemorrhage. I
tell them that the functions that could be affected
without a hemorrhage involve speech, thinking functions, and gait, and that the chances of them being
affected are low, and that, if they are affected, that it
would tend to be to a mild degree.
The above statement highlights several key features
of the informed consent process in DBS. First, there
is a great deal of information for the patients, most of
There are no professional or
manufacturer guidelines establishing
informed consent criteria for
patients undergoing deep brain
stimulation surgery.
whom have no scientific or medical background, to
absorb and comprehend. Second, the risks taken by
the patient are extreme including the loss of speech,
paralysis, or death. Those risks should not be obfuscated by extraneous filler. The amount of information
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