IEEE Technology and Society Magazine - June 2015 - 7

side effects, and resultant social
life changes that implantees (of all
kinds) are faced with post-surgery.
I am not referring here to issues
related to surgical implantation
(e.g., symptomatic haemorrhage
after electrode placement), or even
device failure or hardware-related
complications (of which I have great
concerns that there will be severe
hacking problems in the future).
Rather, I am referring to the resultant effect of "artificially constructed" dynamic stimulation on the
human brain and its impact on an
individual. In short, these are the
unintended consequences, that
range in scope from psychotic symptoms post stimulation (e.g., for epilepsy, or for patients presenting with
auditory hallucinations for the first
time), to modifications in sleep patterns, uncontrolled and accidental
stimulation of other parts of body
function [9], hypersexuality, hypomania [10], changes to heart and pulse
rates, and much more.
Many implantees resort to social
media to share their pre- and postoperative experiences. And while
this is "off the record" self-reporting,
clearly some of these discussions
warrant further probing and inquiry.
My hope is that the copious note-taking that occurs during pilots and clinical trials, specifically with respect
to side effects, will be more accessible in the form of peer reviewed
publication for doctors, engineers,
government officials, standards
organizations, regulatory approval
bodies, and of course, the general
public, so that we can learn more
about the short-term and long-term
effects of neural stimulation devices.
One patient, as a result of a particular procedure in a DBS pilot study
described a sensation of feeling hot,
flushed, fearful, and "panicky." "He
could feel palpitations in his chest,
and when asked indicated he had
an impending sense of doom. The
june 2015

feelings were coincident and continuous with the stimulator 'on' setting
and they rapidly dissipated when
switched 'off'" [11]. Surely, this kind
of evidence can be used to inform
stakeholders towards what works
and what does not, and the kinds
of risks a patient may be exposed
to if they opt-in, even if we know the
same state will not be experienced
by every patient given the complexity
of the brain and body. In the more
mature heart pacemaker industry, it
is device manufacturers who tend to
wish to hoard the actual physiological
data being recorded by their devices
[12], [13]; the brain implant industry
will likely follow suit.
To conclude this editorial, at the
very least, I would like to echo the
sentiments of Fins et al., that deep
brain stimulation is a "novel surgical
procedure" that is "emerging," and
should presently be considered a last
resort for people with neuropsychiatric disorders [14]. There needs to
be some tempering of the hype surrounding the industry and we need to
ensure that rigor is reintroduced back
into trials to minimize patient risk.
Exemptions like that granted by the
U.S. Food and Drug Administration
(FDA) on the grounds of a "humanitarian device" allow implant device
manufacturers to run trials that are
not meaningful because the size of
the trial is inappropriate, lacking commensurate statistical power [14]. The
outcomes from such trials cannot
and should not be generalized.
I would go one step further, calling
not only for adherence to more careful research requirements during clinical trials, but also urging the medical
community in general to really think
about the direction we are moving. If
medical policies like these [15] exist,
clearly stating that "there is insufficient evidence to support a conclusion concerning the health outcomes
or benefits associated with [vagus
nerve stimulation] ... for depres∕

IEEE Technology and Society Magazine

sion" then we must introduce major
reforms to the way that consent for
the procedure is gained.
Between 1935 and 1960, thanks
to a rush of media (and even academic coverage), lobotomies were
praised for the possibilities they
gave patients and their relatives [16].
Although I am not putting lobotomies on the same level as VNS and
DBS, I am concerned about placing
embedded devices at the site of the
most delicate organ in the human
body. If we can "switch on" certain
functions through the brain, we can
also "switch them off."
It is clear to anyone studying
emerging technologies, that the
future trajectory is composed of
brain implants for medical and nonmedical purposes. Soon, it won't be
just people fighting MDD, or OCD,
epilepsy [17], [18], Parkinson's disease [19] or Tourette's Syndrome
who will be asking for brain implants,
but everyday people who might
wish to rid themselves of memory
disorders, aggression, obesity, or
even headaches. There is also the
potential for a whole range of amplified brain technologies that make
you feel better - diagnostic devices
that pick up abnormalities in physiological patterns "just-in-time," and
under-the-skin secure identification
[20]. And while the current costs for
brain implants to fight mental illness
are not cheap, at some $25  000
USD each (including the end-to-end
surgical procedure), the prices will
ultimately fall [1]. Companies like
Medtronics are talking about implanting everyone with a tiny cardiac monitor [21]; it won't take long for the
same to be said about a 24x7 brain
monitor, and other types of daily
"swallowable" implants [22].
Fears related to embedded surveillance devices of any type may

(continued on page 17)

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