Responsible Neuro-Technologies of Pain: Understanding Vulnerability in Pain Care with Minimally and Non-Invasive Neuro-Technologies for Pain Modulation in the United States (REGAIN)

Project Information

REGAIN

Grant agreement ID: 101031798

DOI

10.3030/101031798

Project terminated on 1 August 2023

EC signature date 7 April 2021

Start date 1 October 2021

End date 30 September 2024

Funded under

• EXCELLENT SCIENCE - Marie Skłodowska-Curie Actions

Total cost

€ 246 669,12

EU contribution

€ 246 669,12

Coordinated by

UNIVERSITY OF HAMBURG
Germany

Periodic Reporting for period 1 - REGAIN (Responsible Neuro-Technologies of Pain: Understanding Vulnerability in Pain Care with Minimally and Non-Invasive Neuro-Technologies for Pain Modulation in the United States (REGAIN))

Reporting period: 2021-10-01 to 2023-09-30

Summary of the context and overall objectives of the project

REGAIN investigates how people living with chronic pain use and experience novel neuro-technologies to alleviate pain. Chronic pain is a global health challenge of enormous proportions. Estimates claim that over 1.5 billion people live with chronic pain worldwide. Recently, technologies that electrically stimulate the nervous system to block pain signals promise new avenues to support people living with chronic pain. Especially in the United States, neural stimulation has made a comeback as a low-risk alternative to pain treatment with medication. As a result, patients, physicians, and companies are increasingly experimenting with new types of neuro-technologies that combine data analytics and brain modulation. Examples include wearable or implantable stimulators that operate automatically without requiring a patient’s or physician's supervision.

In this context, REGAIN investigates both the new potentials and risks that these new technologies bring about, especially from the perspective of users. The project uses qualitative methods from the field of Science and Technology Studies (STS) to study users' experience. The project engaged with users over a period of up to one month, for example, through chat interaction, diaries, and interviews. In addition, REGAIN also studies the societal dimension of neuro-technologies of pain, comparing the United States and Europe. As mentioned above, the US opioid crisis often forms the backdrop in front of which neuro-technology is positioned as a good alternative. REGAIN has thus also engaged with experts on the matter, including physicians, patient advocates, and company officials, to understand the broader context in which neuro-technologies are emerging. Here, REGAIN intends to offer a critical analysis of the promises but also potential risks of these technologies. Based on this knowledge, the final aim of the project is to highlight new pathways for developing and governing neuro-technologies for pain management in a responsible way, that is, anticipating risks while harnessing their potential.

The project has been terminated early due to an appointment of the researcher as assistant professor at the Technical University of Denmark. Still, the project made an important contribution to the emerging field of NTP as well as STS. The main preliminary finding of the project is that there are great benefits but also new vulnerabilities emerging especially at the intersection of the brain and digital data. As these issues are complex and interdisciplinary, REGAIN has helped foster new cross-disciplinary alliances between patient advocates, pain physicians, academic researchers, and industry representatives to jointly assess and anticipate potential risks.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the first two years of its runtime, REGAIN collected a plethora of qualitative empirical data including
- documents (scientific and policy publications, company websites, and media articles)
- observational data (field notes written during two relevant conferences related to the topic of neuro-technology and chronic pain)
- expert interview data (especially with physicians and company officials)
- multimedia data from diary studies (interviews, text-based chat histories, photographs & video material)

The project has also conducted preliminary analyses of the expert interview data as well as the documents using discourse analysis. The purpose of this analysis was a critical enquiry into the promises of an emerging landscape of digital neuro-technologies of pain, especially focusing on the positioning and relationship of neuro-tech companies and physicians. The analysis shows that the interaction of patients, their data and neuro-technological interventions does not only change the ways in which people live with pain but also how pain is managed more broadly how neuro-tech companies operate within an economy that increasingly depends on data assets. The researcher (co)presented 5 talks reporting these preliminary results of the project. The talks were given to academic audiences mainly, including at the most prestigious conferences in the field of STS, the EASST Annual Meeting in Madrid (June 2022) as well as the 4S Annual Meeting in Puebla, Mexico (December 2022). These activities helped draw the attention of other STS scholars to the project.

The project convened a cross-disciplinary workshop on “Digital Pain Technology” at Cornell University, in May 2023. The event featured 13 leading experts in the field of pain management and technology. Participants were from industry, patient advocacy, academia, and medicine. The event represented a catalyst of existing efforts to design emerging technology in the service of integrative pain management (see a blog post by one of the participants here: https://painmanagementalliance.org/2023/05/31/advaocating-for-person-centered-pain-care-during-cornell-workshop/). The workshop also reflected on the ethical and social issues around emerging pain technologies and explored novel pathways to design and govern them in a more responsible way.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

REGAIN’s preliminary insights of tracing users’ experience with digital neuro-technology indicate both new potentials as well as vulnerabilities for patients. For example, combining data analytics with neural stimulation can be an effective way of managing pain. Neural data gathered from the patient’s body is used to smartly attune the level of stimulation to the individual condition or even to the time of day. As chronic pain is a highly individual illness and can be very volatile this promises better and more sustainable relief. However, these brain data also pose new risks and ethical problems. For instance, while these data can be highly valuable assets for neuro-technology companies, patients are rarely compensated for providing them or even properly informed about their potential value. A key insight from the collected data is also that patients engage in interfacing and data work to make these technologies function properly. They have to maintain the electrodes, update stimulation parameters, and provide data to the company for these devices to unleash their full potential.

In light of these complex issues, it is essential to open up the conversation to all involved stakeholders. REGAIN made a leap in this regard by convening experts in the field of pain technology and management at the Cornell workshop on digital pain technology (see above). One of the key takeaways from this meeting was that only by bringing these voices together can we achieve the promise of pain technology. Among the challenges of this endeavour is developing a common language around key issues of patients’ rights (e.g. consent), medical bias, digital access, algorithmic justice, and integrative pain management. REGAIN laid the groundwork for further initiatives extending to, for instance, people with lived experience, insurance payers and venture capital.

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