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.
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Image courtesy of CREST Research on Flickr |
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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Image courtesy of Wikimedia Commons |
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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Image courtesy of Pixabay |
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
- 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/.
- 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
- Strauss, A. & Corbin, J. (1990). Basics of Qualitative Research: Grounded Theory Procedures and Techniques. SAGE Publications.
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Want to cite this post?
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