Breakthroughs in the decoding of brain activity using microelectrode arrays in non-human primates and humans, and noninvasive electroencephalography in humans, now enable relatively accurate predictions of upper and lower limb movements. As a consequence, peripheral nervous system interfaces are now being developed to reliably control prosthetic limbs. However, translational efforts to bring these technologies to end-users are confronted with important regulatory, scientific, engineering, clinical, ethical, and financial challenges that stakeholders need to better understand. This is partial support for an International Workshop on Clinical Brain Neural-Machine Interface Systems (BMI, for short) intended to identify and discuss current challenges and potential solutions leading to the development and deployment of interface systems based on neural activity in clinical/home applications. The meeting will be organized by the University of Houston and held at The Methodist Hospital Research Institute (TMHRI) in the Texas Medical Center (Houston), on February 24-27, 2013. The workshop will bring together expert speakers (at both junior and senior levels) and discussants representing the forefront of BMI research, rehabilitation clinicians, neurologists, neurosurgeons, engineers, computer scientists, neuroscientists, program managers at federal agencies, representatives of the industrial sector, end-users and other stakeholders for discussions and interaction in an academic setting with the goal of developing a strategic plan ("roadmap") to bring BMI systems out of the lab and into the clinic/home. Topics to be explored will include: what are the clinical needs and application "pulls" that require BMIs (the "market"); what is the best approach for uncovering basic mechanisms and validating BMI systems technology; what are the scientific, engineering and regulatory challenges that affect clinical use of BMIs, and potential solutions; what are the needs of patients who could benefit from this co-robot technology; how to address potential ethical concerns regarding the use of BMI systems to enhance the body/brain; and how to train the next generation of students in neural and rehabilitation engineering.
Broader Impacts: A "roadmap" summarizing the findings of the workshop will be submitted for peer-review to Frontiers in Neuroprosthetics, a first-tier electronic open access journal devoted to BMI systems. To this end, faculty and graduate students from selected university science writing programs will be invited to blog and write summaries of the group interactions and final group briefings during the workshop; these summaries, edited by the discussants, will serve as drafts of the consensus attained by the participants (minority opinions will also be included). This roadmap will serve as a guide to program managers at federal agencies to develop funding opportunities and support mechanisms to enhance and accelerate the deployment of clinical BMI systems. The workshop organizers will actively recruit participants from under-represented groups, including women and minorities, and across institutions, to ensure that their voice is heard.
In late February 2013, researchers, clinicians, government, foundation and industry representatives, patients and students met in Houston to create a strategic plan or roadmap for accelerating the development, implementation and ultimate translation of clinical BMI systems to the end users. The meeting, known as the 2013 International Workshop on Clinical Brain-Neural Machine Interface (BMI) Systems, was held at The Methodist Hospital Research Institute (now the Houston Methodist Research Institute). The website for the conference (see attached images), including a video-clip of neurotechnology demonstrations, can be found at http://bmiconference.org/. The meeting was also denominated a National Robotics Initiative (NRI) meeting. The goal of this meeting was to identify and discuss challenges and potential solutions leading to the development and deployment of BMI systems in clinical applications. There were three aims: 1) To develop a Strategic Plan ('Roadmap') for accelerating the development, translation and adoption of BMI systems by clinicians and patients; 2) Dissemination of the findings of the meeting to the community at large; and 3) Outreach to junior faculty, postdocs and graduate students from underrepresented groups, including women and minorities, to ensure a wide range of experiences and views and to provide for career development opportunities for the next generation of neural and rehabilitation engineers. The meeting format combined (single track) state-of-the-art talks by senior and junior faculty, clinicians, and speakers from federal agencies with hands-on demonstrations and audience-driven discussions whose content was provided by the participants themselves. The meeting outcomes included: - Independent reports by the science media on the consensus reached at the meeting: Neurotech Business Report; ‘Brain-Machine Interface Pioneers Participate in Workshop on Clinical BMIs’. Staff Report; www.neurotechreports.com/pages/workshop_clinical_brain_machine_interfaces_report.html The Dana Foundation; ‘Roadmapping the Adoption of Brain-Machine Interfaces’. Reported by Kayt Sukel, April 15, 2013; www.dana.org/news/features/detail.aspx?id=42098 - A Published report written by student scribes: Liew SL, Agashe H, Bhagat N, Paek A, Bulea TC. (2013). A clinical roadmap for brain--neural machine interfaces: trainees? Trainees' perspectives on the 2013 international workshop. IEEE Pulse. 2013 Sep; 4(5): 44-8. doi: 10.1109/MPUL.2013.2271686. - The creation of a translational working group on clinical brain-machine interface systems that will draft a regulatory guidance document with the purpose of sharing information to investigators and device developers while they are still in the development process. It is expected that this regulatory roadmap will facilitate innovation and investment in device development and accelerate the translation of technology to patients in need. The translational working group co-chaired by Cristin Welle (FDA) and Jose Contreras-Vidal (University of Houston) plans to meet on February 27, 2014 and public comments on the document will be sought thereafter.
