A few months ago, our blog post discussed a possibility of direct-to-consumer neurotech devices reaching the market in a near future. Among available brain stimulation techniques, transcranial direct-current stimulation (tDCS) is a fairly simple non-invasive method for cortical stimulation. A recent study, conducted by researchers at the University of New Mexico, seems to support the cognitive-enhancing effect of the technique. Learning and performance in a shooting video game was increased two-fold following 30-min tDCS as compared to control, even after one-hour delay. Other studies found beneficial tDCS effects on working and visual memory. Capitalizing on the enthusiasm generated by these studies, the website GoFlow is planning to offer a DIY kit for tDCS with a price tag of $99! Understandably, the kit is very bare-bone, and includes only a battery, a few scalp electrodes, resistor, and a potentiometer. I would venture to guess that the kit would attract avid brain-hacking enthusiasts and perhaps some students desperately trying to memorize the material before the exam. For the rest of us, let’s wait for a more mature product to hit the shelves.
In order to use a medical device in the US, a device manufacturer has to get an approval from FDA. Invasive devices, such as neural implants, are classified as Class III and can be approved in one of two ways: 1) a comprehensive “de novo” Premarket Approval (PMA) or 2) a streamlined 510(k) clearance, also called a Premarket Notification (PMN), when the device is “substantially equivalent” to an existing approved device. The complete device development and approval process takes 4-10 years and costs $5-300 million depending on the complexity of the device and FDA approval process. Approximately 40 PMAs and 3,000 510(k) clearances are approved each year by the FDA.
Cortical and spinal neural implants are among the most invasive and, therefore, always require a PMA approval. In comparison, the “Cranial Electrotherapy Stimulator” (CES) devices, are implanted under the scalp and pose fewer surgical risks. Until recently, they required only a 510(k) clearance, and such relaxed approval process resulted in their multiple applications for neurological and psychiatric disorders, such as anxiety, depression, insomnia, chronic pain, and migraine.
In August 2011, FDA proposed a new rule to require PMAs for CES devices, and the device makers responded by proposing instead that the devices be given less stringent Class II status, which often does not require PMA approval. In February 2012, the Neurological Devices Panel of the Medical Devices Advisory Committee at the FDA advised against such downgrade, so the CES devices would still require a lengthy and expensive PMA process. According to recent estimates, an average PMA approval process would take ~27 weeks and would cost the CES device makers an additional $1 million, as compared to 510(k).
Upper (e.g. bronchial) airways become constricted in people with asthma or chronic obstructive pulmonary disease. The bronchial smooth muscle contraction is mediated by the parasympathetic nervous system, while the relaxation is mediated by the sympathetic nervous system. The periaqueductal gray matter of the midbrain (PAG) and subthalamic nucleus (STN) are involved in maintaining the bronchial relaxation. The electrical stimulation of the PAG is approved for chronic pain and electrical stimulation of the STN – for movement disorders (Parkinson disease and dystonia). A new study by a group of neurosurgeons from Oxford, United Kingdom evaluated the effects of the PAG and STN stimulation with DBS electrodes on the bronchial airway function. They found that activation of both brain structures in awake human subjects produced similar increases in the airway flow of 10-12%, with some patients exhibiting even larger increases (up to 30%). While similar effects were seen in both PAG and STN, the used stimulation frequencies were quite different: 7-40 Hz in PAG and 130-180 Hz in STN. It is important to mention that PAG is considered to be a major integration center for multiple autonomic functions, such as cardiovascular responses, thermoregulation, respiration, bladder and bowel voiding, arousal, and rapid-eye-movement (REM) sleep. This study raises an important question whether asthma is a neurological disorder that can be treated by neuromodulation?
In recent years, the medical manufacturing company Greatbatch Inc. has made several steps indicating its ambition to become a major player in the neuroprosthetic device arena, currently dominated by Medtronic, St. Jude, and Boston Scientific. Until recently, Greatbatch’s two subsidiaries, Greatbatch Medical and Electrochem Solutions, were mostly known for producing the pacemakers, vascular catheters, orthopedic implants, leads, and batteries. The company does not market any neurostimulation devices, although several other manufacturers use Greatbatch’s batteries and leads in their neuromodulation implants (e.g. obstructive sleep apnea device by Inspire Medical). In fact, 95% of all pulse generators worldwide contain at least one Greatbatch’s component. In 2008, Greatbatch created the QiG Group, its third subsidiary, with a goal of making targeted investments in innovative cardiovascular catheters and neuromodulation devices. Last year, QiG has started the Algostim brand of spinal cord stimulation devices to treat chronic pain, The QiG has also invested, along with Boston Scientific, into Intelect Medical, an early-stage company developing deep brain stimulation devices for traumatic brain injury, and stroke. And most recently, on February 17, 2012, Greatbatch’s QiG Group announced its acquisition of NeuroNexus for $12 million. Dr. Daryl Kipke, NeuroNexus President and CEO, indicated that its technologies would be used to develop novel “neuromodulation clinical therapies”. It remains to be seen whether the Greatbatch’s definition of “neuromodulation” will be modified, as the key NeuroNexus technologies, the high-density silicon-based electrodes and their interconnects, are more suited toward neuroprosthetic rather than neuromodulation therapies. But, in any case, this news brings us one step closer to a long-awaited clinical trial of probes developed using the semiconductor microfabrication technologies.
The ICNPD-2011 conference took place on November 25-26 2011 on the campus of University of New South Wales in Sydney, Australia. As a co-chair of the conference, it is my great pleasure to report on its results. The conference drew 70 participants, and included 25 speakers from 9 countries (Australia, China, Denmark, Germany, Korea, Singapore, Taiwan, UK, and USA). Owing to a multi-disciplinary nature of the neuroprosthetic research, the talks were given by scientists, engineers, neurosurgeons, and rehabilitation physicians and covered a wide range of topics, such as new materials, surgical approaches, uses of electrochemical and neurophysiological recordings, circuit design, and signal processing algorithms. During the poster session, 16 posters were presented, including 8 student posters evaluated by the members of Scientific Committee. The Best Student Poster award, the iPad2, was given to Dr. Spencer Chen, a post-doctoral fellow at the University of New South Wales; and the runner-up award was given to Dr. Chandan Reddy, a post-doctoral fellow at the University of Iowa. Following the conference, a series of online discussions were held with the speakers to come up with a list of Grand Innovation Challenges in Neural Prosthetics: http://neurotechzone.com/icnpd-2012/grand-challenges. These challenges are subdivided by the following clusters: Visual prosthetics, Auditory and vestibular prosthetics, Motor/BMI prosthetics, neuromodulation for pain control, Electrode-tissue interface, Insulation and encapsulation, and Packaging. This list will continue to be updated based on your feedback, so please read it thoroughly and don’t forget to leave your comments.
A subset of these challenges will be selected, based on your input, for discussion at the ICNPD-2012 that will take place later this year in Freiburg, Germany: http://neurotechzone.com/icnpd-2012
The neuroscientists at UC Berkeley conducted the study in 15 patients with epilepsy or brain tumor, in which the subdural electrocorticographic (ECoG) recordings were used for deciphering the speech processing in the cortex. Brain activity was induced in the superior and middle temporal gyri, the cortical regions involved in speech comprehension, by listening to words. Each word was played to a patient for 5-10 minutes to collect enough data for analysis. The spectral features of the sounds were used for linear and non-linear regression algorithms in order to reconstruct the words from the pattern of brain activity. The reconstructed words were intelligible enough to recognize them, although they sounded as if spoken under water. The proposed technology is still rather immature but one day it hopefully would be able to convert the ECoG activity in the auditory cortex into spoken language for patients with a stroke, locked-in syndrome, and other disorders resulting in a paralysis of their vocal cord and arms (think of Stephen Hawking).
During stimulation, the applied electrical charge induces similar flows of multiple extracellular cations (K+,Na+ and Ca2+) in the electrode vicinity. This is rather counter-productive as these cations play varying roles in the initiation and propagation of action potentials. As a result, a significant percentage of applied electric charge is being wasted. Now, scientists at MIT and Harvard Medical School have reported a way to alter the cation concentrations using commercially available cation-selective resin solutions deposited on planar electrodes. In one experiment, they applied small positive DC current (≤1µA, 10 to 100 times below the nerve activation threshold) to a centrally-located calcium-selective electrode for 1 min to deplete Ca2+ concentration from the fluid surrounding the nerve. Immediately thereafter, they applied the supra-threshold electrical pulses between two lateral uncoated electrodes, while the central electrode was off. The researchers achieved a 70% decrease in the amount of current required for reaching the nerve activation threshold. In another experiment, the K+- and Na+-selective electrodes were used to deplete the concentrations of these ions at some distance from the stimulating electrode. Such cation depletion caused a complete conduction block for 10 min after applying a cation-depleting DC current of 1µA for 5 min. Both K+- and Na+-selective electrodes were equally effective in blocking the action potential propagation. This finding could have important applications in shutting off the nociceptive neural activity in relieving chronic pain. Finally, the developed cation-selective electrodes have two important features making them attractive for neuroprosthetic applications: 1) they can be microfabricated and 2) they do not require a chemical reservoir for their operation.
About 3 -4% of the general population has or will develop a cerebral aneurysm, with most are without any symptoms. Aneurysm is an enlarged area of a blood vessel that usually develops at a branching point of artery and is caused by constant pressure from blood flow. It often grows gradually and becomes weaker as it stretches. Rupture of a cerebral aneurysm causes bleeding into the brain, often leading to a stroke. Endovascular embolization using micro-coils has emerged as a successful preventive treatment for aneurysms. The micro-coils are made from platinum wire (thickness 20–120 μm) wound at diameters of 200–500 μm for length up to 50 cm. Once the coil is inserted through the artery into the aneurysm, it forms a randomly tangled globe that promotes clotting of blood, thus preventing further inflow of blood and pressure rise. In about half of implanted patients,
the embolization process fails within 18 months, requiring frequent checks for the blood entry into the aneurysm using expensive, invasive, and potentially toxic methods, such as X-ray angiography and computer tomography. The group of Dr. Takahata at the University of British Columbia has reported a new method for monitoring blood entry into aneurysms, which is simple and inexpensive enough for frequent monitoring at home. In their method, the RF resonance of the micro-coils is used as a moisture sensor. The RF resonant circuit is formed by self-inductance combined with parasitic capacitance, which is affected by tissue permittivity around the coil. At 100 MHz, for example, the dielectric constant of blood is 25 times higher than that of fibrous tissue. The RF coupling of the micro-coils would be done with an external antenna attached to the head of a patient. The present study was conducted using animal muscle tissues, with a clinical device
anticipated in 2-3 years.
As documented in other posts on this blog, mutliple neural prosthetic devices are currently being developed by startup companies throughout the US, Europe, and Asia. Practically all of these startups are pursuing the well-established R&D strategy of building a device to treat a specific neurological disorder and going through a lengthy process toward eventual FDA approval and reimbursement by private and government-run health insurance companies. In following with this R&D strategy, the resulting device is usually fully implanted and contains only the circuitry needed for its primary function to treat a specific disorder. The device is designed for autonomous operation without user accessibility, and any device’s software tuning/upgrade requires a physician and specialized clinical equipment. These features are aimed at limiting the manufacturer’s and surgeon’s liabilities.
Here, I would like to propose a possibility of developing the consumer-oriented neural interfaces. Such a strategy is inspired by recent developments in the consumer electronics industry and, particularly, by a wide adoption of body-worn health monitoring gadgets (such as a sleep sensor Lark, EEG monitoring device Mynd, and muscle stimulator Compex). The proposed new strategy requires a fundamental shift in the user attitudes toward body-worn neural interfaces. Instead of treating the neural interface as a “band-aid” for restoring the lost or damaged neurological function, the users would treat the neural interface as a sensory or motor extension of their existing own nervous system. The following table illustrates the key attributes that differentiate a conventional neurological treatment device from a consumer-oriented device:
|Attribute||Conventional device||Consumer-oriented device|
|Usage||Repair of lost/damaged neural functions||Enhanced use and preventing the decay of existing neural functions due to Alzheimer’s|
|Customer||Hospital, doctor||End user|
|Reimbursement||Health insurance company||End user|
|Implanted components||Electrodes, active electronics||Electrodes only (minimally-invasive placement)|
|Body-worn interface (BWI)||Telemetry for battery re-charging and data input/output||User-controlled multi-purpose graphical computer interface|
|Placement of BWI||Inconspicuous or hidden from view||Prominent|
|Operation of BWI||Primarily by a physician||By the end user|
|Communication with other devices||None (standalone use)||Standard wireless protocols (Bluetooth, WiFi, 3G)|
As can be seen in the table above, the fundamental changes in the R&D strategy relate to every aspect from the device marketing to its configuration, operation, and user control. The reduced complexity and size of the implanted device are crucial for allowing a minimally invasive implantation that can be performed by a neurologist (rather than a neurosurgeon) in an outpatient clinic. Fabrication of a simple implantable device combined with a simple surgery can dramatically reduce the overall user cost (perhaps to a sub-$10,000 level) and therefore make the devices applicable for non-medical applications, such as memory improvement, cognitive training, and around-the-clock personal assistance.
Continuing the parallel with the consumer electronics, let’s think for a moment about our computer use just 10 years ago. The computers back then could serve specific functions, such as data entry, word processing, accounting, etc. Our everyday lives, however, have been rather “un-tethered”, as we lived our lives oblivious to a possibility of having constant access to our email inbox or a Facebook status. There is no denying, that we are evolving into a new social species, the “homo twitterus”, with the reported ~60% of smartphone users waking up voluntarily during the night to check their messages. Let’s compare that with our evolving attitude toward the neural interfaces. In the classic SciFi movies Star Trek: First Contact (1996) and The Matrix (1999), a images of the brain and spinal interfaces were positively repulsive. A decade later, in the movie Tron: Legacy (2010), the Identity Discs worn by the Grid inhabitants, prominently featured on their back, appear rather attractive and stylish. The public interest in the consumer-oriented neural interfaces may start initially among the techno-gadget aficionados and gradually spread to general population. Similar evolution has occured with the computer use and has now reached the stage where pure functionality and low cost of the device are no longer as important as its esthetic, social-status, and “coolness” appeal (think of Apple’s Macbook Air, iPad, and iPhone). While many Android phones are arguably more feature-rich and less expensive than iPhone 4S, Apple Inc. is enjoying robust growth by strengthening its deep personal relationship with customers and by changing their lifestyle in a profound way. The proposed consumer uses of neural interfaces can bring such device-user relationship to a whole new level, with the person’s everyday life being dependent on bidirectional exchange with their body-worn personal assistant. A rich virtual environment provided by the neural interface can be used, for example, by retired baby-boomers for muscle exercise and rehabilitation; memory improvement and cognitive fitness; and learning of visual and motor skills (e.g. golf, tennis, driving). Many other applications, perhaps even more pervasive and lifestyle-changing (such as novel sensory/motor modalities), could emerge as the neural interface technology takes hold in the society.
As the number of people with Alzheimer’s disease (AD) is rising with aging population, there is an increasing urgency in developing an effective approach to slow its progression. Despite the efforts by pharmaceutical companies, currently approved drugs provide only modest effects and are often difficult to target to the brain without avoiding the systemic side effects. A possibility of using electrical stimulation for combating the disease has not been considered until a serendipitous discovery reported in 2008 by Dr. Andres Lozano, a neurosurgeon at the University of Toronto. He applied the DBS stimulation at the satiety-controlling region of the brain, the fornix, in a patient with morbid obesity with a hope of reducing the sensation of hunger. Surprisingly, the psychological tests have shown a significant improvement in patient’s memory. The follow-up study in AD patients, published in 2010, showed that the fornix stimulation can slow the memory decay. The authors of the study speculate that possible mechanism of action involves plasticity in the limbic circuitry counteracting the AD-related neurodegeneration. As a result of these findings, a startup company called Functional Neuromodulation Inc. was formed in 2010 to commercialize the DBS use in the fornix for AD patients. It recently obtained funding from Genesys Capital and Medtronic to conduct the second clinical trial in the AD patients. It is worth mentioning that other companies, such as Medtronic and St. Jude Medical, have considerable intellectual property on electrical stimulation of other limbic areas, such as the anterior thalamic nucleus, internal capsule, and subgenual cingulate cortex, which may also play an important role the memory formation process. We will anxiously await further developments in the use of DBS to counteract the progression of AD.
The quest for highly functional neuroprosthetics in activities of daily living has implicitly assumed that the neural interface would include both motor and sensory (i.e. tactile and proprioceptive) functionalities. It is likely that for reaching and grasping tasks, the dynamic sensorimotor programs will need to be developed to enable dexterous control. Interestingly, the neural decoding, stimulation, and hardware principles for sensorimotor interfaces are often developed in isolation in motor-only or sensory-only studies. In this week’s issue of the journal Nature, a new study was published by Prof. Nicolelis group from Duke University attempting to create a bi-directional sensorimotor neural interface for reaching tasks. Primates used both direct brain motor control and artificial tactile sensory feedback delivered back to the brain to complete the task. Both the motor and sensory channels bypassed the subject’s body, effectively liberating a brain from the physical constraints of slow nerve implse propagation through the nervous system. Potential use of such bidirectional control is not limited to artificial limbs and can include fast communication with a variety of external sensors and actuators.
Kip Ludwig, who was recently appointed as program director in repair and plasticity at the NIH National Institute for Neurological Disorders and Stroke, will deliver the keynote address at the 11th annual Neurotech Leaders Forum, which will take place in San Francisco on October 17-18, 2011. Ludwig will offer attendees his views on his new role with the NIH and how it impacts the neurotechnology industry.
Ludwig received his Ph.D. in Bioengineering at the University of Michigan, followed by post-doctoral work at the same institution. More recently, Ludwig worked in industry at CVRx as a research scientist, where he and his team conceived, developed and demonstrated the chronic efficacy of a next-generation neural stimulation electrode for reducing blood pressure in both pre-clinical and clinical trials.
The 2011 event will also feature an in-depth session on reimbursement issues affecting neurotechnology manufacturers in light of new health care reform legislation.
Venture capital professionals Heath Lukatch of Novo Ventures, Paul Grand of RCT BioVentures, Mikhail Shapiro, formerly of Third Rock Ventures, and Jonas Hansson of HealthCap in Sweden will participate. Other speakers include Don Deyo, vice president of R&D at Medtronic Neuromodulation, medical device reimbursement expert Tom Hughes, and Victor Pikov of Huntington Medical Research Institutes.
The 2011 event will feature a first-ever Consumer Neurotech Conference on October 18, the second day of the event. The full-day meeting will include sessions on neuromarketing, gaming, training, and cognitive enhancement applications of neurotechnology. Companies represented on the agenda include EmSense Corp., NeuroSky, Inc., and Technology Partners. Victor Pikov will also speak on neural interface lifestyle issues.
For more information on the 2011 Neurotech Leaders Forum, including sponsorship opportunities, call 415 546 1259.
As described in the September issue of Nature Communications, Prof. Rolandi ‘s team at the University of Washington, Seattle has created the first solid-state transistor that controls the flow of protons instead of electrons. This is much more practical for transmission of information in biological tissues than electrons, as protons can freely interact with ions. The key challenges in developing proton-based electronics are to find the right materials for pumping and conducting the protons. In the developed prototype transistor, the pumping action is mediated by palladium, which can absorb hydrogen and create a hydride that easily accepts and donates protons. The protons then flow through a 3.5-micrometer-wide channel made from nanofibers of chitosan, a polysaccharide extracted from the chitin shells of crustaceans (such as crabs and shrimp). The prototype is built on the silicon substrate, but the final device would probably use a more biocompatible material. The protonic transistor behaves like a traditional field-effect transistor, with the current flowing between the source and drain under the control of the gate. The ability to modulate the current flow in this protonic transistor is rather limited (by a factor of 10) compared to high gain ratios in conventional electronic transistors (x10,000). Unlike these conventional transistors, the protonic one does not have a p-n junction to block the current when the device is off. So, the protonic transistor functions more like a variable resistor than a switch. Despite its limitations, it is a big step toward more natural neuronal stimulation, as the device is easy to fabricate and is more stable than previous attempts, using microfluidics and thin films.
Migraine is a highly prevalent neurological disorder, affecting more than 10% of people (6% of men and 18% of women) worldwide. It is not surprising, therefore, that all three of the major neurotech device manufacturers, Medtronic, St. Jude Medical, and Boston Scientific, have evaluated their implantable stimulators for treatment of his chronic condition. Multiple areas have been targeted for treating migraine; with most common ones being the occipital nerves and the cerebral cortex. The latter approach is usually accomplished non-invasively with the transcranial magnetic stimulation and is most helpful for patients whose migraines begin with an aura, a condition characterized by flashing lights or other visual (or sometimes sensory, motor or verbal) disturbance. The occipital nerve stimulation is more generally applicable to migraine sufferers, and involves a chronic implantation of the stimulating device. The clinical trials have been performed to see whether any of the devices could clear at least one of two FDA-mandated thresholds: a 50% reduction in migraine severity or a 50% reduction in migraine frequency. Boston Scientific’s pivotal trial PRISM was completed in 2009, showing no significant improvements. Medronic’s pivotal trial ONSTIM was completed in 2010, indicating that 39% of patients achieved 50% reduction in migraine frequency. St. Jude Medical’s pivotal trial ended in June 2011 and was, perhaps, the most successful of the three: they reported an overall 28% reduction in migraine frequency and 42% reduction in migraine severity. Although these results are insufficient for the FDA clearance, the St. Jude Medical’s Genesis device was able to receive the European CE mark approval in September 2011. This gives the first-mover advantage to St. Jude Medical in Europe, but the battle for the lucrative US migraine market is still waging on.
As Victor Pikov astutely noted in an earlier blog post, there are robust efforts to increase neurotechnology research, development (R&D), and production in China. This is not incidental; neurotechnology renders considerable capability and potential to improve quality of life – both directly and indirectly. In the former sense by enhancing medical care and human performance, and in this regard one need only think of the ability to assess, discern and better diagnose neurological disorders by using neurogenetics, neuroproteomics, and various forms of neuroimaging, and the therapeutics made possible through selective neurotropic drugs, peripheral and central neural stimulating devices, transcranial magnetic and deep brain stimulation, and neuroprosthetics. In the latter sense the benefits of neurotechnolgy are financial, achieved by neurotech companies and the national economies that profit from their revenues.
Therefore, it becomes important to consider how neurotechnology could be used to leverage economic – and socio-political – influence on the world stage. The old adage that “the one who controls the chips controls the game” is metaphorically appropriate in that efficient production of neurotechnologies can foster a presence in worldwide biotech markets, and the use of neurotechnologic devices in China (for example, conducting neuroscientific and neurotechnological research in Chinese medical institutes) can be attractive to global investment partners, due to the frequently reduced costs and time required to execute such studies. And given that much of the microcomputational circuitry used in neuroS&T (neuroscience and technology), irrespective of where it is made, is being increasingly produced in China, the adage may have literal validity, as well.
This steadily growing prominence of non-Western nations in the field of neuroS&T gives rise to a number of important considerations and concerns. First, is that we are witnessing a shift in global economics, influence, and capabilities, and neurotechnology is a factor in the current and future re-balancing of this power equation. It’s no longer simply a case of “…the West and the rest”, but rather that non-Western countries such as China are becoming a scientific, technological and economic force to be reckoned with.
Second, the needs, desires, ideals and practices of Western societies may not be relevant or applicable to the ways that enterprises such as neuroS/T research, development, testing, evaluation (RDTE) and use are viewed and conducted in non-Western nations. This generates “who’s right?” scenarios that involve issues of what and how the values and practices of a particular group of people can and should be regarded and responded to – a point raised by philosopher Alasdair MacIntyre and recently addressed by Alan Petersen of Monash University in Australia. For example, should a stance of “when in Rome, do as the Romans do” be adopted, and if so, does this mean the employment of certain guidelines and regulations in the country that is involved in neurotech research and product development, and different guidelines and regulations for each and every country that utilizes such neuroS&T? Or could some uniform codes of research and use be viable in any and all situations – and if so, how might these codes be developed and articulated?
Third, technological and economic capabilities engender “cred and clout” at international bargaining tables, and so the social and professional values of those countries that are gaining and sustaining momentum in neurotechnological research and production will become ever more prominent, important, and therefore necessary to acknowledge.
Working in our group, Misti Andersen and Nick Fitz are studying these issues, and together with Daniel Howlader, are addressing how various philosophies and ethics inform national neurotechnology policies (in the USA, EU, and Asian nations, including China). Collaborating with social theorist Roland Benedikter of Stanford University, we are examining how the shifting architectonics of biotechnological capability are affecting the philosophical and ethical Zeitgeist that characterizes the “new global shift” and its manifest effects in healthcare, public life and national security on the world stage.
These issues span from the scientific to the social, in that neuroscience can be employed to explore, define, and manipulate human nature, conduct, and norms, and neurotechnology provides the tool kit for neuroscientific research and its uses (or misuses). Moreover, not every country that is dedicating efforts to neuroS&T maintains the same ethical standards for research and/or use that have become de rigueur in the west. How shall we engage those countries that do not strictly adhere to the Nuremburg Code, or Declarations of Geneva and Helsinki, yet generate products and devices capable of affecting the human predicament or condition (e.g.- by providing state-of-the-art treatments for neurological and psychiatric disorders or performance enhancement), and in this way incur significant economic power in global markets? Should we adopt some form of moral interventionalism that would seek to enforce particular Western ethical standards upon the conduct of non-Western neurotechnological R&D, or do we posture toward more of an isolationist stance? And in the event, how would we then maneuver our neurotechnological R&D to retain a viable presence on the global technological and economic map?
In this blog and elsewhere, I’ve claimed that it is exactly this scientific-to-social span of neurotechnological effect that necessitates programs dedicated to the ethical, legal and social issues inherent to neuroS/T. But, as I mentioned in my earlier blog post, if neuroethics is to be globally relevant, then it must be sensitive to pluralist values, and cannot be either an implicit form of neuroscientific and technological imperialism, or succumb to ethical laissez faire.
A complete discussion of my take on the fundamental premises and precepts of the discipline and practice(s) of neuroethics is beyond the scope of this blog. But, one of the key points I believe is important to emphasize is that neuroethics must be grounded to a bio-psychosocial framework that recognizes the interaction and reciprocity of biology and the socio-cultural environment.
Culture is both a medium in which bio-psychosocial (e.g.- genetic, phenotypic, and environmental) variables are generated, and a forum that defines how such variables may be expressed. So, while our species certainly has a host of common biological features, we also differ – and these differences occur as a consequence of cultural factors, and in contribution to socio-culturally patterns of cognitive and behavioral variability.
The “take home” message here is that our biological, psychological and social aspects manifest both commonalties and differences, and any meaningful ethics would need to take these factors into accord. Philosopher Bernard Gert’s concept of “common morality” may be viable to some extent, but ethical values and systems also manifest distinctions in standpoint, and therefore ethics would need to at least acknowledge, if not frankly recognize these distinctions in perspective in a discursive way. This brings us back to MacIntyre’s question of “which rationality” should be used in approaching ethical issues and resolving ethical questions.
Perhaps it’s not so much a question of “either one form of rationality or another”, but rather more a position of “both/and” in these situations. If neuroethics is to authentically represent a naturalistic orientation to human cognition, emotion and behaviors, then I think that it’s vital to appreciate the ways that bio-psychosocial (viz.- cultural) differences are manifest, and in this appreciation, adopt an ethical approach that is more dialectical. Thus, I’ve called for a cosmopolitan neuroethics that seeks to bring differing viewpoints to the discourse, and is not necessarily wedded to a particular theory or system, but instead is open to all, relative to the circumstances, benefits, burdens and harms that are in play and at stake.
Now, you might be thinking, “Isn’t cosmopolitan ethics a particular theory or system?” and to some extent you’d be right; but before we write off the term and concept as self-contradictory (i.e. an antinomy, something that cannot be “a” and at the same time claim “b”), let’s regard it more as a “way” of doing ethics that seeks complementarity in perspective, orientation and approach, so as to enable a richer, more complete discourse from which to foster synthetic solutions. This would allow us to move away from a “West and the rest” position, to more of a naturalist view of the human and human condition, that would be open to differing views and values, and would seek to define core concepts that could be employed in specific ethical situations and deliberations.
Neurotechnology can and likely will affect biological, socio-cultural, economic and political realities in numerous ways, and if we are to develop well-informed, ethically sound guidelines and policies that are best-suited to the complexity of these circumstances, then the need for an inclusive, cosmopolitan neuroethics becomes apparent. The really hard part is making it work.