Neural engineering (NE) science has reached new frontiers. It has the potential to help ameliorate chronic diseases such as Tourette’s Syndrome and Parkinson’s Disease, and to be combined with other modalities (such as artificial intelligence) to manage conditions such as obesity, diabetes and heart disease.
In this new research landscape, neuroengineers, clinicians and patients work together to develop neural devices that achieve optimal benefits for patients and caregivers. Patients are no longer merely the hosts or subjects – they are becoming co-scientists in the innovation process. There is an increasing need for clinicians to receive patient feedback and data, and this workshop has identified several key reasons why we need more input from patients. Since clinicians and researchers don’t always know what patients need, it also allows clinical assumptions to be tested and adjusted based on real-world use or patient preference.
Treating neuroscience research patients as co-scientists in their own protocols can have beneficial psychological effects, can result in better therapy compliance, and could contribute to a successful outcome for the patient and the project. However, the NE community must balance the need for patient input with the host of global, cultural and gender-related differences that will affect preferences and feedback.
Financial constraints are an obstacle for the NE clinical community because many of their innovations are highly individualized and not designed to be immediately scalable for commercialization.
The 2017 clinical workgroups reinforced the belief stated in 2015 that in this new era of innovation, physicians and neuroengineers are partners on the “clinical team.” This theme was repeated throughout the sessions. Researchers can feel distanced from the clinical aspects of the protocols, especially what’s working well and what isn’t, and the clinicians feel that a deeper understanding of the engineering aspects will inform their clinical procedures.
To improve understanding of every team member’s capabilities, neural engineers should engage with the medical field they’re trying to impact, and clinicians should spend time with neuroengineers. In addition, both need to spend time with end-users, caregivers, and physical and occupational therapists to better understand the synergies, mechanics, and therapeutic aspects of device/patient interactions. “Opening up” to other collaborators teaches all team members about how they fit, what others contribute, and how important each contribution is.
There is one clinical environment in which neuroengineering challenges are mitigated. The Veteran’s Administration (VA) is a unique key player in the NE community. Its research and services are fully dedicated to injured veterans who have served honorably in the United States military. “The VA takes care of its people – period,” one workgroup member stated. As part of its mandate, the VA must maintain specialized treatment and rehabilitation programs for spinal injuries, blindness, amputations, mental illness, and other serious service-connected health conditions. As a result, many typical barriers to research and treatment, including tight funding limitations, are not present, and VA neuroengineers and clinicians enjoy greater flexibility and support to develop and deploy new technologies. Another benefit of the VA system (and not typical in the public sector) are the variety of ancillary services, training and support provided to caregivers, whom they value as critical ongoing support for their veterans.
Fortunately, the VA also cares about translating successful technologies out to non-VA patients. This makes them a valuable partner and ally for the NE community. The VA is also an anomaly with respect to development costs and budgets, since cost is less important to them than providing optimal patient care. VA researchers also have protected research time – they can investigate a variety of solutions without as much concern for marketability or commercial value.
What are the most cost-effective technologies? Cost only goes down as demand increases, and the NE field is designing customized devices for small, specific populations, so their commercialization value is questionable.
American distrust of science and scientists
This increasing negative perception is affecting the NE research community. Workgroup members discussed the need to educate the different social, generational, political and ethnic communities and rebuild trust by sharing good information, answering questions and maintaining an open line of communication.
Increasing global perspective
Healthcare, both economy and practice, is adopting a more global perspective. Healthcare is not a single country’s challenge. The approach to healthcare and delivery of technological solutions, however differs widely across the globe. Continued dialog and solutions require increased focus on global context.
The enabling of widespread data sharing could greatly impact the success and efficiency of trials. The total NE patient population is relatively minuscule, so an enlarged data pool would provide broader and richer study information for better decision-making. This could help investigators focus on the most productive research, avoid duplicating other work, and speed successful product development.
An increase of promotion of this style of support: including family, friends, counselors, clinicians, occupational and physical therapists, and even healthcare aides, will help to achieve lasting self-agency and success. Unfortunately, long-term support systems are inconsistent in different geographies and healthcare networks. When a grant runs out, what happens to the patient? Some patients are great at adapting; others are not.
A neuroethical framework
Despite many questions circulating about neuroethics and its place in the work of the NE community, no framework has yet been established to navigate the murky ethical issues. Where should the line be drawn between ‘rehabilitation’ and ‘augmentation’? How do we categorize memory implants for Alzheimer’s patients, and devices such as exoskeletons? Should functionality be delivered at any cost? How should the community support hundreds of people with fully implanted devices after the trials are over? These issues and others will continue to emerge, and they require consensus guidance upon which to base ethical decisions.
We envision clinical efficiency in developing and deploying breakthrough solutions that maximize self-agency and balance risk with reward to improve the quality of life for individuals living with diseases or disorders of the nervous system. The goal is to help restore users’ self-agency and participation in their communities of choice through a collaborative, inclusive, multidisciplinary, biobehavioral approach.
Goals (2 to 5 years)
Improve bi-directional interaction between neural engineers and clinicians
Create a dedicated Neuroengineering Session at a major clinical conference.
Create a Cleveland NEW travel award for students/postdocs to present abstracts at clinical meetings of their choice.
Develop a mentorship pairing program for neuroengineering students to attend clinical meetings
Develop a toolkit for undergrads, grad students, post-docs, young investigators, and senior investigators to engage in direct interactions with patients.
Increase clinician participation in Cleveland NEW:
Determine which clinicians were invited this year and send email to ask them why they didn’t come, what would entice them to attend.
Compile list of regional (driving distance or short nonstop flight) clinicians that the group would like to have participating in 2019.
Describe specific interactions requested from these clinicians.
Define views on “augmentation;” a neuroethical framework
One degree shifts
Establish award eligibility for Cleveland NEW travel award and determine target number of awards and funding amount
Create target list of potential clinical conferences. Request to incorporate more NE in each conference. Request a list of possible mentors for NE grad students
Compile descriptions of formal BME course-related experiences that already exist.
Describe mechanisms for:
inviting patients to course lectures
inviting students to disease support groups,
identifying clinical mentors integrating students into neurology/neurosurgery clinics that would allow them to listen to patients’ discussions about their disease and treatments.
Survey past Cleveland NEW clinicians as to why they didn’t attend. Target clinicians to invite in 2019 who are in the local region. Develop a list of younger clinicians to invite.
Plan modifications to next Cleveland NEW workshop format to encourage clinician attendance
Create a list of potential neuroethics training opportunities
Participate in a neuroethics training