Neuroethical Considerations of DBS and aDBS

Neuroethics is a multidisciplinary field aiming to assess the ethical, legal, and social implications of challenging brain-centered topics that are emerging in the scientific, medical, legal, psychological, spiritual, and cultural spaces. DBS and aDBS are both subject to different levels of review due to the varying concerns associated with both technologies.

Privacy of Brain Data

Given the state of aDBS technologies' current uses, it seems that the data gathered by IPGs is focused on the movement-related firing of action potentials from targeted neurons. The current state of the research community's interpretation of such data beyond this framing is limited, and therefore ultimately is of low to medium risk of the data violating patient privacy if acquired beyond practitioners. However, this may not be the case for the future use of other BCIs. Given the enormous potential for progress in understanding the mechanisms of the brain beyond our current knowledge of the field, the likelihood of future interpretation of cognitive outputs through the reading of neuronal signals similar to aDBS is not unfounded. With this in mind, we as a society must determine how valuable we find our mental autonomy and brain data privacy, and determine whether we find it necessary to protect it through regulatory measures.

Data is a valuable asset in a capitalistic society. Intel on an individual or population's behaviors, interests, and wants can help shape products and services catered to their respective populations. Further, advertising techniques for specific items can be customized to reach specific audiences and infiltrate different markets based on predictive information about different population demographics1. "Neuro-feedback" and "attention supervision" devices are just two examples of technologies designed by startup companies introducing headbands and helmets targeting stress management, concentration, and sleep through unregulated devices1. This field is being promoted as "well-being therapies," and information is gathered, stored, and accessed by consumers via smartphone apps1. The danger of this type of neurotechnology is that it can certainly be used to target marketing toward individuals with mental health, attention, and sleep disorders. If information about their respective conditions is learned through interpreting neurological biosignals through their apps, they may be subject to intentional advertisements of products without knowing the cause or they may benefit from seeing a provider rather than use a device they are frequently exposed to through advertisements. While this is certainly looking beyond our current limitations of interpreting neuronal signals, the concern may not be too far from being a reality.

Questions of violating Neurorights are also a highlighted worry under neuroethical analysis, as the field has highlighted the limited protections of rights to mental privacy (unauthorized data collection), mental integrity (harmful manipulation of brain activity), and cognitive liberty (freedom of thought and conscience), which are currently not protected by existing legal defenses in most national regulatory jurisdictions1. Challenges to protecting these rights include the difficulty of classifying future data types and distinguishing mental data from biological data. Despite the potential obstacles in achieving a consensus on what falls into these respective definitions, aspects of mental autonomy may be in jeopardy of violations without structured legal defenses against their infringement and misuse.

Justice of Resource Allocation

Another concern with regards to DBS vs aDBS technologies is the difficulty managing who receives these technologies and the limitations that come with access issues with respective providers when the technology is novel to the healthcare scene.

DBS is already a rather limited care process when it comes to accessibility, given that a surgical procedure is necessary for the implantation of the device, and that there are limitations on how many providers are familiar with and can manage patients with operating DBS and post-surgical care. Issues of cost, geo-access to locations, geographic availability of centers that can provide treatment, as well as the willingness of providers to refer and continue treating patients with the implant pose justice barriers when there is not equitable opportunity for all2.

We anticipate that this issue will only be further exacerbated with aDBS technology, where the device requires the additional skillset of an AI specialist/AI designer familiar with neuroscientific mechanisms of the disease as well as the technology embedded in the device to adjust any technological errors with the added complexities of the aDBS device. Further, with the technology being rather novel, there is a question of how updated versions of devices will be allocated: will patients be entitled to updated versions of technology as they are released, or is there a disclosure of the permanence of the device they receive? Transparency of resource shortages, extensive informed consent, and collaborative communication between patients and their providers is imperative to limit the potential harm to patients using these devices and maintain respect for patient autonomy. Moreover, the acknowledged barriers to access should collectively be an ongoing item addressed by the respective company bringing the product to market.

Enhancement vs. Treatment

While aDBS's current uses are limited to specific neuronal conditions, the status of aDBS as a BCI (brain computer interface) gives reason to consider whether there is a need to design parameters around potential treatment (and enhancement) through neuronal medical devices. With 2 terms with which there is often overlap, it is imperative as a society that we work towards distinguishing what qualifies as enhancement and what is a treatment in different contexts so that they can ultimately guide how we incorporate those interpretations into our medical device policy.

The primary question we must consider is, where is the source of our sense of self, or really "what is the self?"3 If the self is fixed and unchanging, despite outside influences, we can reasonably say that electrical stimulation into the brain via DBS/aDBS technology would not change who a person is, and therefore would not be a form of enhancement. However, evidence citing behavioral and psychological changes that result from targeted stimulation to brain areas serves as a counterargument to this theory3. Further, another dimension of the enhancement-treatment debate is that one's sense of self is a condition of the brain at one given time. Therefore, it has been influenced by its environment and influences leading up to a moment in time when the self is measured, whether that environment and influences are intentional (electronic stimulation) or not3 .

If we decide that the self is unfixed and rather plastic, and if we decide to explore such technology that could influence the brain (and therefore one's self) beyond our current understanding, we must think of the necessary boundaries that should limit over-reaching into enhancement measures. As a society, do we agree that moral enhancement (using such means to make individuals more morally attuned to right and wrong actions) is a permissible use of this type of technology? What about other BCIs with more complex features- are they held to the same or different standards? Do we believe the infringement on freedom of thought and actions is more important than working towards a morally like-minded society?

The question of treatment versus enhancement only further complicates the matter when contextualizing intention of use. If a patient is prescribed aDBS as a course of treatment to manage abnormal brain function, then the rationalization leans more into being permissible on the grounds of improving functioning to reach a general threshold of normal existence. However, with the potential associated with these types of devices, there is the possibility for a more recreational use of the device - despite there currently being a barrier, with surgical implantation being a necessary part of the process- is an item to note when considering whether aDBS provides too much of an advancement, and whether we need to enforce prescribed treatment-only use3. aDBS can operate on dopamine systems in the brain, which could potentially be abused as a alternative to addictive neuro-enhancers and suppressants like pharmaceutical drugs. However, regulation that could target this concern would include the need to tighten the medical device market and limit the selling of non-medical specific devices accross the country, potentially hampering innovation along the way.

Evidently, this question is of particular contention and debate; however, just because the questions are difficult to answer does not mean they may not be issues in the long run for society and the medical/ research communities. While there are currently some forms of enhancement regulation in the pharmaceutical space, we will only continue to see its scope expand to neuronal medical technology. To this point, in order to put forth any necessary boundaries to protect individuals from these dilemmas in the future, we should continue working towards answers for what constitutes enhancement versus treatment through medical device interventions.

Citations

1. Vidal, Catherine. 2022. "Neurotechnologies under the Eye of Bioethics." eNeuro 9 (3): ENEURO.0072-22.2022. https://doi.org/10.1523/ENEURO.0072-22.2022.

2. Johnson, Kara A., Nico U. F. Dosenbach, Evan M. Gordon, Cristin G. Welle, Kevin B. Wilkins, Helen M. Bronte-Stewart, Valerie Voon, et al. 2024. "Proceedings of the 11th Annual Deep Brain Stimulation Think Tank: Pushing the Forefront of Neuromodulation with Functional Network Mapping, Biomarkers for Adaptive DBS, Bioethical Dilemmas, AI-Guided Neuromodulation, and Translational Advancements." Frontiers in Human Neuroscience 18. https://doi.org/10.3389/fnhum.2024.1320806.

3. Frank, Lone. 2018. The Pleasure Shock: The Rise of Deep Brain Stimulation and Its Forgotten Inventor. New York: W.W. Norton & Company. 6-38.