FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2892549203> ?p ?o ?g. }

• W2892549203 endingPage "S248" @default.
• W2892549203 startingPage "S244" @default.
• W2892549203 abstract "Traumatic spinal cord injury (SCI) is a significant life event, one that often defines a fixed time point: life before SCI and life after it. However, the rise of new neuroprostheses may introduce a new point to this timeline, one that could be as precise as the injury itself: the restoration of volitional movement and perhaps even sensation. Neuroprostheses offer possibilities that may forever change physical and psychological experiences after SCI. Yet it is important to balance excitement about these possibilities with consideration of the ethical dimensions of the study and use of these technologies. Previous work on the ethical dimensions of neuroprostheses has focused largely on the broader implications of these and similar technologies once they become more widely available 1, 2. In this article, we focus on the local issues of neuroprosthetic research in its current stage of development and their effects on research participants and cli006Eic patients after SCI. We highlight 4 ethical issues with novel neuroprostheses: co-investigatorship, explantation, off-target effects, and societal responsibilities. Through introducing these issues in the context of current research, our hope is to begin a conversation regarding these new technologies and to propose methods for ongoing consideration of ethical issues as this research progresses. Acute, traumatic SCI traditionally is associated with loss. Loss of volitional movement, loss of sensation, loss of bowel/bladder control, and loss of independence may all accompany this condition 3. However, in-depth research may introduce a gain to balance this loss: the role of co-investigator. Implanted neuroprostheses, especially the many new technologies involving brain–computer interfaces (BCIs), introduce the possibility of bypassing focal impairments in the nervous or musculoskeletal systems 4. These BCIs can be used invasively 5 or noninvasively 6. In their exploratory current state, significant training is required to tune interfacing neurons to specific patterns that can then be interpreted by computer algorithms and translated into functional end effector commands. Recently, this has been accomplished in patients with SCI by using the participant's brain to control peripheral functional electrical stimulation in their own muscles 7 and also in a bidirectional manner, in experiments in which a brain-controlled robotic arm directly conveyed sensory feedback from the robot back to the somatosensory cortex 8. These applications, and the many that are still in early planning phases, require a significant investment in time and energy from the participant with the implanted device. This is needed not only to fine-tune the neuron firing patterns within the participant that are then read by the BCI but also to optimize the computer algorithms needed to decode these signals. Given this intense training and time commitment from both participant and researchers, the participant gradually may become more of a co-investigator than a passive volunteer, exploring new scientific frontiers along with the research team and making scientific contributions by providing technical insights not otherwise freely available. Many participants, and the researchers pushing the knowledge boundaries alongside them, discuss their experiences in terms of this pioneering partnership. Ian Burkhart, who was one of the first participants in an experiment to connect a BCI to the limb of a person with paralysis, says, “I really can't complain about the way my life is right now. If nothing else, I can say I was the first person ever to do something, which is an opportunity I never expected to have” 9. This novel role for the participant may provide a notable sense of self-worth and meaning but also can blur ethical boundaries. For instance, in a recent article reporting on the use of a BCI to control a robotic arm, the research participants, Tim Hemmes and Jan Scheuermann, are included in the publication as co-authors of the study, and the article includes descriptions by Hemmes and Scheuermann of their experiences participating in the research 10. It is likely that there are other studies in which participants played similar roles as Hemmes and Scheuermann but were not credited. The question remains at what threshold research participants become co-investigators proper, requiring due credit in publication. A retrospective review may be helpful to determine how common co-investigatorship has been and whether cases are increasing. Furthermore, ethical analysis is needed to determine in which cases co-authorship is an appropriate reflection of the working relationship and when it could be used to influence participant decisions within the study itself. Indeed, numerous studies have shown that researchers and participants have divergent expectations and risk tolerance with regard to SCI research outcomes 11, 12 and diverse functional priorities for BCI use 13. Given these differences between participants, clinicians, and researchers regarding the purpose of such research, special protocols may be needed to ensure that expectations are discussed and disagreement is fairly adjudicated. Investigators especially will need to be on guard against novel biases and misconceptions emerging from this new form of researcher–participant relationship. In addition to preempting potential issues early on through recruitment procedures and informed consent language, additional outside review may be needed to address unexpected conflicts as they emerge throughout the research process. The situation could become further ethically ensnarled when the experimental time period is over and the participant must transition away from their role as a pivotal team member on cutting-edge science to that of an outside observer. To date, there has not been any focused research on participants' potential feelings of loss from no longer being a part of an investigative team, or, comparably, beneficial feelings of pride from this experience. As BCI neuroprostheses become more popular, further research is needed to better quantify these psychosocial reactions, not just the raw neural signals reduced to device commands. Planned explantation of implanted neuroprostheses presents additional ethical issues. When experimental neuroprostheses are implanted, there are usually clear expectations that the device will be removed at a given time point due to increased risks of infection for the participant 14. Current devices with implanted recording components also experience signal degradation from the innate foreign-body reaction over time around implanted electrodes 15, 16. Yet it is difficult to ensure that the participant (or the researchers themselves, for that matter) is truly informed as to what this explantation will mean at some future time point. At the very least, explantation often involves a potentially dangerous surgery, one that the participant could very reasonably refuse for health concerns alone. However, an additional consideration is that of integration of these devices into a participant's self-image. Research has demonstrated that individuals with SCI often assimilate their wheelchairs as an extension of their physical bodies, a requisite extension of themselves to achieve needed mobility 17, 18. A similar phenomenon may occur with this next generation of even more closely integrated assistive devices (BCI), further complicating how we provide information for informed consent to these potential participants. Although participants may cognitively understand and be able to consent to research that will restore or replace their abilities to stand, walk, reach, etc, both researchers and participants may not understand the true psychological implications of abruptly taking those capabilities away. Rehabilitation medicine providers are intimately aware of the benefits to quality of life that seemingly incremental improvements in a realm such as hand function can have for patients. The ability to grasp a pen or text a loved one can provide an immense source of pride and independence. Being subsequently stripped of these abilities through explantation may prove a significant blow, reopening the wounds of the initial loss from traumatic SCI. An eerily similar situation is that of removing ventilatory assistance from a dependent patient with acute SCI. In this setting, many ethicists, psychologists, and rehabilitation medicine providers have suggested that patients should undergo a “time-limited trial” to see what living with an SCI is truly like before such withdrawal of care 18. These professionals argue that a patient in an acutely traumatic situation, often with little actual knowledge of what living with paralysis would be like, is poorly equipped to make an informed and life-ending decision to withdraw the ventilator. To some fractional degree, a participant agreeing to explantation of a neuroprosthesis before experiencing restoration of lost abilities—an experience that may be identity-altering in itself—may not be able to truly be “informed” as to what this will mean. Although proposing a time-limited trial of a neuroprostheses may not be an equivalent solution for this issue, acknowledgment during the initial consent process by researchers of the potential future internal conflict volunteers may experience may be helpful. A further issue with explantation, which we also raise herein, is responsibility for device maintenance if explantation is not chosen. If explantation is refused by the research participant, do the researchers or sponsoring corporation have an obligation to make hardware or software available for use? A real-world example of this in the SCI medicine realm is the Freehand device. This implanted functional electrical stimulation device was marketed by NeuroControl Corp from 1993 to 2001 and stimulated individual muscles to improve tenodesis grasp for patients with cervical SCI. After NeuroControl discontinued the Freehand System and later went out of business, many patients with implanted devices scrambled for spare parts from company warehouses 19, relying on a network of good Samaritans to distribute these life-changing pieces of defunct technology. Although one may be hard pressed to mandate that companies provide continuous lifetime support of all devices, an argument could be made that they have at least some moral obligation to assist these research volunteers who risked their own health to advance the science from which these companies directly benefited. Attempted restoration of one particular system may actually have off-target effects that restore another system's function. A fitting example of this is epidural stimulation. Although the vast majority of early research focused on this neuroprosthetic approach to restoring volitional lower extremity movement after SCI 20, 21, recent research has been built on the finding that these participants reported incidentally improved bladder and bowel function as well 22. Should further findings with other neuroprostheses be similar, would these effects be considered “off-label” applications of this technology? Any such off-target effects would likely be held to the same standard of reaching some minimal clinically important difference regarding outcomes. Although targeted trials could be designed to quantify these off-target effects, it is notoriously difficult to generate consistent data about many rehabilitation medicine outcomes, such as spasticity, within an often heterogeneous, small patient population 23, 24. For many of these difficult to objectively quantify realms, the intrinsic mechanisms contributing to their varied clinical presentations are likely insufficiently understood (at least to the degree needed to predict outcomes from the host of altered contributory neural signals). This, paired with our incomplete understanding of the full effects of many stimulatory neuromodulation techniques, increases the possibilities that we may bumble our way into some unanticipated solution while exploring these neuroprosthetic technologies. Awareness that these off-target effects may exist is crucial when attempting to anticipate and plan for future ethical conflicts. Compounding this issue, these unexpected effects may vary based on incremental alterations of stimulating lead placement or stimulation parameters of many BCI. With a great deal of individual customization required for implantation/algorithm tuning of these devices, the paradigm is notably different than that of a systemic medication that acts similarly in the vast majority of individuals. If a motor system-based BCI does little to improve ambulation but improves bladder function or spasticity, is it the responsibility of providers to adjust the device to address only the targeted (and potentially approved) functional deficits? When off-target applications are incidentally found and preferred by the patient to the traditional target, is it appropriate for payors to deny coverage? These and other key questions are important to consider as BCI take an increasingly prominent role in management decisions. As these neuroprosthetic technologies become more accepted and eventually approved, questions of how society assigns value to them loom. We are currently witnessing a potential test case to this scenario with robotic exoskeletons for patients with SCI; these devices are transitioning from the research arena to commercial products. Although research on the physiologic effects of these devices is ongoing, they continue to capture our collective imagination and serve as a physical manifestation for technological advancement in the field of rehabilitation medicine. In 2015, the Department of Veterans' Affairs began providing coverage for such robotic exoskeleton 25, and in 2016, a German court ruled that a health insurer was required to pay for a robotic exoskeleton 26. Currently, other private insurances in the United States have reportedly also approved such exoskeletons for home use 27. If history is any indicator, the costs for these early neuroprosthetic devices and requisite training will be substantial. Society will likely need to weigh the benefits of these devices relative to the costs—unless access to them is judged to be a fundamental human right subject to protection under the Americans with Disabilities Act, as in the 1999 case of Olmstead v. L.C. 28. Similarly, payors must balance the monetary costs of these devices with their responsibilities to other patients. We all would like to be able to provide more and better treatment options for our patients, but as a society, we also must grapple with the ever-escalating costs of such new options. Although it can be uncomfortable for many of us to disassociate and monetize such decisions, how much is a neuroprosthetic system that marginally improves spasticity or improves bladder function worth? Would these resources be better spent on half a year of hemodialysis? Annual examinations for 500 patients? Or ought we to change the qualifying thresholds of Medicaid to prune borderline individuals off and recoup the costs? As the decision is highly dependent on benefits experienced by those with implanted devices, payors will likely require some objective measure that they are getting a return on their investment in these devices. On the surface, this seems like a simple request. However, as these neuroprosthetic devices will likely have the ability to record detailed logs of use, it will be tempting to capture and disseminate these data. This raises legitimate concerns about the privacy of the user. Patients may be given the choice of accepting such surveillance in exchange for the ability to use such a potentially life-changing device. Employing such usage monitoring may further bias selection of who should receive coverage for such devices against those with other limiting impairments/comorbidities 2. Furthermore, if off-target effects are discovered and preferred, these metrics assessing the approved target may be exceedingly difficult to achieve. Clear guidelines will need to be established before widespread adoption of these devices to address these potential ethical issues and protect the privacy and rights of those with the greatest disabilities. Given these potential issues with payors and access to developing technologies, another issue is that of the do-it-yourself neuroprostheses movement. Although this subculture of life-hackers and hobby scientists 29 has been thus far relegated to the fringe of individuals looking for a cognitive edge, as augmentative technologies improve, the potential for patients with SCI venturing into this space increases. Without clearly addressing the psychological effects of implanted/explanted neuroprostheses and planning policies for dealing with off-target effects and coverage responsibilities, clinicians risk marginalizing some patients and pushing them toward this deregulated space. As rehabilitation medicine providers focused on functional improvement of patients, we are gifted insights into patients' inner lives. Leveraging these insights, a thorough conversation discussing these range of ethical issues should be had both with researchers and industry partners and any individual future patient who is considering self-integration with these technologies. We thank Dr Michael Selzer for encouraging us to think about the ethical issues involved when research participants take on co-investigator roles in research. This is a rich topic, and we are only able to brush the surface in this review. We hope that this will be the subject of future research, especially in cases in which children are the patients who become co-investigators." @default.
• W2892549203 created "2018-10-05" @default.
• W2892549203 creator A5001651204 @default.
• W2892549203 creator A5042482337 @default.
• W2892549203 date "2018-09-01" @default.
• W2892549203 modified "2023-09-27" @default.
• W2892549203 title "Ethical Issues Surrounding a New Generation of Neuroprostheses for Patients With Spinal Cord Injuries" @default.
• W2892549203 cites W1230353723 @default.
• W2892549203 cites W1461517903 @default.
• W2892549203 cites W1760660508 @default.
• W2892549203 cites W1796170220 @default.
• W2892549203 cites W2080947784 @default.
• W2892549203 cites W2086775000 @default.
• W2892549203 cites W2090223961 @default.
• W2892549203 cites W2098716676 @default.
• W2892549203 cites W2104105197 @default.
• W2892549203 cites W2107635023 @default.
• W2892549203 cites W2112073593 @default.
• W2892549203 cites W2124311300 @default.
• W2892549203 cites W2142004558 @default.
• W2892549203 cites W2147571546 @default.
• W2892549203 cites W2153156720 @default.
• W2892549203 cites W2269768844 @default.
• W2892549203 cites W2316565135 @default.
• W2892549203 cites W2531012506 @default.
• W2892549203 cites W2603380332 @default.
• W2892549203 cites W2613941319 @default.
• W2892549203 cites W2727352756 @default.
• W2892549203 cites W2767856142 @default.
• W2892549203 doi "https://doi.org/10.1016/j.pmrj.2018.05.020" @default.
• W2892549203 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/30269809" @default.
• W2892549203 hasPublicationYear "2018" @default.
• W2892549203 type Work @default.
• W2892549203 sameAs 2892549203 @default.
• W2892549203 citedByCount "1" @default.
• W2892549203 countsByYear W28925492032020 @default.
• W2892549203 crossrefType "journal-article" @default.
• W2892549203 hasAuthorship W2892549203A5001651204 @default.
• W2892549203 hasAuthorship W2892549203A5042482337 @default.
• W2892549203 hasBestOaLocation W28925492031 @default.
• W2892549203 hasConcept C118552586 @default.
• W2892549203 hasConcept C1862650 @default.
• W2892549203 hasConcept C2778334475 @default.
• W2892549203 hasConcept C2780775167 @default.
• W2892549203 hasConcept C71924100 @default.
• W2892549203 hasConcept C99508421 @default.
• W2892549203 hasConceptScore W2892549203C118552586 @default.
• W2892549203 hasConceptScore W2892549203C1862650 @default.
• W2892549203 hasConceptScore W2892549203C2778334475 @default.
• W2892549203 hasConceptScore W2892549203C2780775167 @default.
• W2892549203 hasConceptScore W2892549203C71924100 @default.
• W2892549203 hasConceptScore W2892549203C99508421 @default.
• W2892549203 hasLocation W28925492031 @default.
• W2892549203 hasLocation W28925492032 @default.
• W2892549203 hasOpenAccess W2892549203 @default.
• W2892549203 hasPrimaryLocation W28925492031 @default.
• W2892549203 hasRelatedWork W1491647394 @default.
• W2892549203 hasRelatedWork W1988409500 @default.
• W2892549203 hasRelatedWork W1990329424 @default.
• W2892549203 hasRelatedWork W1992812138 @default.
• W2892549203 hasRelatedWork W2057041836 @default.
• W2892549203 hasRelatedWork W2377889806 @default.
• W2892549203 hasRelatedWork W2386002113 @default.
• W2892549203 hasRelatedWork W2397227860 @default.
• W2892549203 hasRelatedWork W2408835491 @default.
• W2892549203 hasRelatedWork W4255897707 @default.
• W2892549203 hasVolume "10" @default.
• W2892549203 isParatext "false" @default.
• W2892549203 isRetracted "false" @default.
• W2892549203 magId "2892549203" @default.
• W2892549203 workType "article" @default.