Case Study: Neurotechnology
Multiple national-level research projects are under way around the world with the goal of revolutionizing understanding of the human brain, in the same way that the Human Genome Project transformed the understanding of the genome (International Brain Initiative, 2020). Just as the Genome Project has enabled both the reading of genomes and the modification, synthesis, and writing of genomes, the growing and evolving understanding of the brain is now enabling both monitoring and modulation. Neural modulation technologies have the potential to offer significant benefits to individuals and society, including through life-changing treatments and therapies for patients and the potential to mitigate cognitive decline associated with aging among other benefits (e.g., Anderson et al., 2020; Lee et al., 2019; Reinhart and Nguyen, 2019). At the same time, these technologies also raise a new constellation of ethical and societal issues, including questions about personal identity and autonomy, data security, equity, fairness, and legality (NIH, n.d.).
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In particular, neural interfaces—frequently used to describe electronic devices that are placed on the outside or inside of the brain or other components of the central and peripheral nervous system to record or stimulate activity—both raise complex questions for society and are increasingly available both clinically and direct to consumer (DTC) in products designed to observe, interpret, and modify human brain function.
Neural interfaces with narrow applications are already in use in health and medicine. For example, deep brain stimulation, which requires surgical implantation, is approved by the FDA to treat patients with conditions such as Parkinson’s disease, essential tremor, epilepsy, and obsessive-compulsive disorder and is being studied in the treatment of other disorders of mood, behavior, and thought (Lee et al., 2019). Transcranial magnetic stimulation (TMS) is being used to treat patients with major depressive disorder and obsessive-compulsive disorder and is being studied in the treatment of pain, addiction, post-traumatic stress disorder, traumatic brain injury, and other conditions (Anderson et al., 2020). External, wearable interfaces are being studied and in some cases being used clinically in people with major depression, chronic pain, stroke and spinal cord injury rehabilitation, and epilepsy management (Avila et al., 2021; Brinkmann et al., 2021; Pedrelli et al., 2020; James et al., 2018).
Transcranial direct current stimulation (tDCS) is a noninvasive neuromodulation technology that is portable, relatively inexpensive, and relatively safe when used within safety guidelines (Elsner et al., 2020). Though the technology has been around for decades, interest in (see Figure 1) and availability of the technology have dramatically increased over the last decade. tDCS is being increasingly used in research on psychiatric disorders, cognitive and motor performance, epilepsy, and other health conditions; is being used clinically (primarily for major depression and chronic pain) in a number of countries (e.g., Singapore and Canada); and is available commercially, in modified forms, for consumers motivated by health, wellness, and enhancement applications. This availability persists despite the controversy that remains regarding the mechanism of action of tDCS and the fact that the evidence base to support clinical translation remains limited (Regner et al., 2018; Kekic et al., 2016). This case study’s focus on tDCS was driven primarily by two factors: first, there is both a history of use and governance that can be traced and learned from, and there is promise of continuing evolution of the technology going forward; and second, this technology has had a clear impact across at least three sectors, with significant footprints in research (academic sector), clinical care (health care sector), and DTC treatments (volunteer/consumer sector).
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