Using Qualitative Methods in a Neuroethics R01 Grant to Investigate Patient Perspectives on Closed-Loop Neurostimulation

By Cailin Lechner, Celeste Fong, and Winston Chiong

This post is part of a series featuring authors who have received the Neuroethics R01 (Research Project Grants) supported by the NIH BRAIN Initiative. These research projects specifically address prominent ethical issues arising from emerging technologies and advancements in human brain research.

Image courtesy of CREST Research on Flickr

New technologies that modulate brain function have tremendous potential for alleviating the burden of treatment resistant neurological and neuropsychiatric disorders, but they also raise challenging ethical and societal questions regarding self-ownership and control over thoughts, emotions, and actions. There is a greater impetus now to consider the potential concerns that may arise with growing societal investment in new circuit-based treatments for brain diseases. Our work studies the ethics of closed-loop neurostimulation techniques across different applications (clinical and research; movement disorders, epilepsy, and mood disorders), using the perspectives of patients, researchers, and clinicians in order to inform conceptual debates.

Current conceptual literature presents concerns about adaptive neurotechnologies like closed-loop deep brain stimulation (DBS) significantly altering patients’ self-concepts and their relationships to other people. For example, could a device that records and interprets a patient’s brain state and applies electrical stimulation to the brain lead to the patient behaving in ways that are unprompted, unexpected, or unlike him or herself? While such concerns have arisen in case reports, a broader empirical base is needed to evaluate their prevalence and importance to patients, particularly given the severity of the underlying neurological and neuropsychiatric conditions that implanted devices are intended to treat. Otherwise we will not be able to balance putative threats to human values, including threats to identity and autonomy, against claims for relief from suffering that are also ethically urgent.

Our study is designed to address conceptual claims and concerns surrounding novel technologies by focusing on the first-hand experiences of patients who are using neurostimulation devices. Ultimately, our work aims to ensure that patient perspectives can be used to inform the design and engineering of neurostimulation devices, as well as guide clinician interactions with patients who have these devices implanted. We attempt to elicit these ethical considerations of closed-loop DBS through three project aims addressing: 1) current clinical applications for epilepsy, 2) current research applications for mood, particularly depression, and 3) investigator perspectives, including those involved in the development and application of neuromodulation technologies.

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Aim 1 of the grant focuses on clinical applications of closed-loop stimulation for epilepsy; we compare RNS to resection cohorts. Aim 2 studies research applications of closed-loop stimulation through two ongoing research cohorts: 1) Parkinson's with comorbid depression and 2) treatment-resistant major depression. Mood, particularly depression, poses questions that may not be encountered in neuromodulation for motor disorders, in part given the close relationship between the neural systems involved in mood and those involved in personality, motivation, valuation, and other valued individual traits. Finally, Aim 3 will make use of focus groups and clinician/investigator interviews to understand what providers are most concerned about and what researchers prioritize in the use and development of closed-loop stimulation devices.

For patients with medically refractory epilepsy, surgical resection of their seizure focus remains the gold standard of treatment. Unfortunately, resection is not always a viable option if, for example, an individual’s seizure focus maps onto a vital function, such as movement or language, or if an individual has bilateral epilepsy, as in the infamous case of patient HM. As of 2013, patients with complicated seizure foci may instead undergo surgery for the Neuropace Responsive Neurostimulation (RNS) System, a chronically implanted, closed-loop neurostimulator. The electrical leads in this device sense and record epileptiform activity, and deliver stimulation to interrupt electrographic seizures. As RNS has been implanted in approximately 1,300 US patients (NeuroPace, 2017), these patients have valuable perspectives to offer to the neuroethics debate over closed-loop DBS.

Aim 1 of our project follows the experiences of patients with RNS for epilepsy and their caregivers for approximately one year after implantation using the qualitative social science research method of ethnography: observations of clinic appointments and conducting semi-structured interviews with patients and caregivers. During clinic encounters, our ethnographic fieldworkers gain insight into patients’ engagement with their neural data. The RNS system allows patients to examine individual recordings of their seizures and patterns in brain activity over time. However, patients may only access these data during clinic appointments with their epileptologist, who functions as a data translator. We have observed that for many patients, their neural data represent a form of new knowledge, answering (at least in part) long unresolved questions about their disease, as well as helping to guide practical and lifestyle decisions. The clinic setting also allows us to witness interactions between patients, caregivers, and care providers firsthand, noting differences in communication style and primary concerns regarding treatment.

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We supplement clinic observations with in-depth interviews, which grounds conceptual concerns about closed-loop neurostimulation in the context of patients’ multifaceted, lived experiences. Shortly after surgery and again one-year post-operatively, our ethnographers meet patients in their homes and discuss their illness history, hopes for medical care, and personal background. Through a modified grounded theory approach (Strauss & Corbin, 1990), our interviewers piece together narratives as patients, for instance, recall their initial concerns going into surgery or share how they explain the RNS System to family members. Conducting interviews in patients’ homes, we have found, enhances our interviewers’ understanding of patients’ stories and creates a space for patients to demonstrate vulnerability. Many interviews, for example, have focused on the impact of epilepsy and the RNS System on patients’ feelings of safety and independence, and fears of uncertainty regarding seizure events. While most patients do not explicitly use the terms “identity” and “autonomy,” several interviews have touched upon these topics.

In addition to continuing observations and interviews with resection and RNS for epilepsy patients, our team is currently applying these methods within our Aim 2 cohort to better understand the experiences of research subjects undergoing closed-loop neuromodulation of mood. The themes we glean from our Aims 1 and 2 data will inform future interviews and focus groups with investigators as part of Aim 3.

References

1. NeuroPace Closes $74 Million Equity Funding to Accelerate Patient Access to the World's First Brain-Responsive Neurostimulation System to Treat Epilepsy. (2017, October 24). Retrieved from https://www.neuropace.com/neuropace-closes-74-million-equity-funding-to-accelerate-patient-access-to-the-worlds-first-brain-responsive-neurostimulation-system-to-treat-epilepsy/.
2. Squire, L. R. (2009). The legacy of patient H.M. for neuroscience. Neuron, 61(1), 6–9. doi:10.1016/j.neuron.2008.12.023
3. Strauss, A. & Corbin, J. (1990). Basics of Qualitative Research: Grounded Theory Procedures and Techniques. SAGE Publications.

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Cailin Lechner is a research coordinator in Dr. Winston Chiong’s Decision Lab within the University of California, San Francisco Department of Neurology. She earned her bachelor’s degree in human biology and society with a concentration in bioethics and public science policy from the University of California, Los Angeles. Her combined experiences in ethnographic neuroethics research, Alzheimer’s advocacy, and community-based social justice work inform her interest in the relationship between individual narratives and health policy.

Celeste Fong is a research coordinator in Dr. Winston Chiong’s Decision Lab in the Department of Neurology at the University of California, San Francisco. Prior to her arriving in California, she completed her master’s degree in Bioethics at Emory University in Atlanta, Georgia, and her bachelor’s degree in Neuroscience at the University of Alabama at Birmingham. She is interested in exploring how advances in neuroscience research and neurotechnology can challenge society’s perception of itself and its values. 

Dr. Winston Chiong is an Associate Professor in the UCSF Department of Neurology, Memory and Aging Center, and is the Principal Investigator of the UCSF Decision Lab. His work is informed by his interdisciplinary training in clinical medicine, philosophy and cognitive neuroscience. He received his PhD degree in philosophy from New York University and his MD degree from UCSF. He completed an internship in internal medicine at Stanford University and a residency in neurology at UCSF. He then underwent postdoctoral research training in cognitive neuroscience and neuroimaging at UC Berkeley and clinical training in dementia at the UCSF Memory and Aging Center. Dr. Chiong’s current research at UCSF has two main focuses: 1) the neural basis of medical and financial decision-making processes in aging populations and 2) the ethical and social implications, informed by patient experiences, of new brain-based therapies.

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Lechner, C., Fong, C., & Chiong, W. (2020). Using Qualitative Methods in a Neuroethics R01 Grant to Investigate Patient Perspectives on Closed-Loop Neurostimulation. The Neuroethics Blog. Retrieved on , from http://www.theneuroethicsblog.com/2020/02/using-qualitative-methods-in.html