Metrics for Brain Controlled Communication: A comprehensive review of clinical outcome assessments for communication brain computer interfaces in amyotrophic lateral sclerosis - PROJECT SUMMARY/ABSTRACT
Approximately 25,000 individuals in the US are currently living with amyotrophic lateral sclerosis (ALS), an
ultimately fatal neurodegenerative disease that progressively impacts motor function. Patients may live for years
after the onset of symptoms that result in complete loss of written and verbal communication, which drastically
decreases quality of life, increases caregiver burden, and creates a significant barrier to life extending care and
ALS research efforts. Communication brain computer interfaces (cBCIs) offer a unique opportunity for completely
movement-free communication for those with severe paralysis due to ALS or other causes. Prior work with
Blackrock Neurotech cBCI technology has developed methods to control keyboards, decode handwriting, restore
speech, and restore verbal communication in locked-in ALS patients. In conjunction with development of our
ground-breaking cBCI technologies, we hope to lead the market in the development of a comprehensive
knowledgebase of how cBCIs affect ALS patients and how future advancements can better improve the lives of
those with this irreversible, fatal condition. Our long-term goal is to establish and validate standardized clinical
outcome assessments (COAs) to capture (1) the needs and values of ALS patients, their caregivers, and
healthcare providers as they relate to communication and cBCIs, (2) patient perceptions of cBCIs, (3) capacity
and efficacy of communication using cBCIs, (4) healthcare and quality of life impacts of cBCIs on patients and
caregivers, and (5) financial and health economic impacts of cBCIs in the ALS population. Given the relative
novelty of cBCIs as an option for ALS patients and the variation within and across cBCI technologies, there is a
critical need to better understand how cBCIs are clinically assessed and to establish a framework for future
development of COAs for cBCIs in patients with ALS. Our objective is to develop a deep and wide-ranging
understanding of (1) the current clinical and scientific landscape surrounding cBCIs, (2) the assessment of their
impacts and efficacy, (3) the strengths and weaknesses of current COAs, (4) patient needs and their perceptions
of cBCIs, and (5) to evaluate areas for future COA development. UH2 development will comprise a
comprehensive literature review and a series of interviews with key opinion leaders to establish a base of
knowledge as well as expert perspectives on the current COA landscape related to cBCIs and the ALS patient
population. UH3 development will occur in collaboration with Johns Hopkins University, Rancho Los Amigos
National Rehabilitation Center, and the University of Utah and will consist of a series of patient and caregiver
focus groups to gain insight into clinically meaningful concepts and endpoints related to communication and cBCI
technologies. At the conclusion of this project, our expectation is that we will have comprehensively assessed
the current landscape of COAs for cBCIs and identified a clear path toward future development of COAs to aid
in clinical application and assessment of cBCIs to enhance the lives of those with advanced ALS.
