Brain chips are not for sending tweets: they’re for restoring the joys of life
Severe paralysis can affect anyone, at any time, regardless of age, gender, or socioeconomic status, rendering you unable to move and speak all the while preserving your cognition. Etiologies among the most prevalent are Spinal Cord Injury (“SCI”), Stroke, Amyotrophic Lateral Sclerosis (“ALS”), Traumatic Brain Injury, Multiple Sclerosis, Cerebral Palsy, and Muscular Dystrophy.
Despite being a diverse population, people with severe paralysis share one common goal: to express themselves again and participate equally in society as autonomous individuals. This yearning unites their community as it does ours; expression sits at the foundation of all human experience.
Figure 1; Gleason, 2014: A quote from a former NFL player with ALS. Reprinted from public materials from the Team Gleason Foundation
Whether someone’s expression was snatched from them in an instant or if it slowly degraded over time, there still remains no cure for paralysis.
Motor BCIs are stepping up to the challenge by finding ways to extract bodily commands and harness them to control devices before they are nullified by paralysis. The more they can tell us, the more we can restore. Before exploring their achievements, you should get familiar with the problems they are attempting to address.
Innate attempts at fine control of a) upper limb, b) lower limb, and c) speech articulators can be extracted as electrophysiological data streams at enough spatiotemporal resolution to convincingly emulate their function.
The emulation can be executed at near-average human speeds, sufficient for performing typical day-to-day activities.
The end-to-end system is safe, reliable, lasting, and portable enough to be commercialized as a take-home product.
For most people, Motor BCIs can improve their connection with technology. For people with severe communication and mobility difficulties (”Users”), however, they represent the hope to reclaim their agency, expression, independence, and participation in society.
Academic labs have demonstrated the technical feasibility of BCIs, but clinical adoption lies in the hands of private firms. As the scientific endeavor tips over into an engineering one, the world watches closely.
As customary in the deep technology sector, many leading scientists have launched commercial ventures of their own, commercializing their academic work in the shape of: Neuralink, Paradromics, Synchron, Precision Neuroscience, ONWARD, CorTec, Blackrock Neurotech, NeuroXess, and INBRAIN Neuroelectronics.
This handful of high-performance Motor BCI startups share over $2 billion in funding without a single product approved for use in the clinical market by regulators such as the Food and Drug Administration (”FDA”).
Prevalence, Costs, and Comparators
1M most downtrodden
Among those most impaired are individuals affected by Locked-In Syndrome (”LIS”), characterized by aphonia (loss of voice) and quadriplegia, but preserved cognition.
Such is the fate of those diagnosed with ALS, a no-cure progressive degeneration of motor neurons, responsible for 55% of LIS cases, or those affected by a sudden brainstem stroke, causing 25% of LIS cases (Pels et al., 2019).
In total, roughly 1 million individuals are destined to be locked inside their own bodies at any given time (Mehta et al., 2017).
21M severely impaired
Characterized by requiring electric wheelchairs with postural support and speaking aids (referred to as Augmentative & Alternative Communication ”AAC”), roughly 21 million individuals seek to restore their independence, expression, and participation (WHO and UNICEF, 2022).
While the characteristics overlap, the etiologies are diverse. In addition to the aforementioned, another large population to share these characteristics are the survivors of high cervical (C1-C4) SCI (Shepard Center, n.a.)
The prevalence of SCI significantly varies between countries. In the US, however, roughly 1 in 1000 people live with SCI (Singh et al., 2014). Nearly 1/3 of them, according to a large-population study by Amidei et al. (2022), with high cervical lesions.
Revisiting stroke: Roughly 101 million people (or 1 in 80 people) live with stroke (WSO, 2022). Approximately 5% of them suffer from severe dysarthria (speech paralysis) without aphasia (language incomprehension) (Mitchell et al., 2021), suggesting healthy cognition without vocalized expression.
While therapies vastly differ between conditions and severities, most individuals experience only slight improvements in mobility and expression — if any at all — and rely on attendant care to perform most activities of daily living.
Costs and Reimbursements
Lead by the cost of attendant care (~$150k), the annual cost of care for severe paralysis is approximately $350k, including ~$54k incurred in lost wages (DeVivo et al., 2011, Obermann and Lyon, 2014, Oh et al., 2015):
Figure 2; uCat, 2023: Visualization of the costs of severe paralysis per individual per year (pro-rata) —
Combining the findings of DeVivo et al. (2011), Obermann and Lyon (2014), Oh et al. (2015), charges were primarily gathered from SCI data (n=1000+) as ALS data included a smaller sample size. Ventilation was the only cost derived from ALS dataset. The analysis focused on the U.S. market, converting the purchasing power of the dollar to 2023, rounding to the nearest 1000th below $50k and 10,000th above 50k.
In the US, much of this cost is covered by the health insurance provided by the Centers for Medicare & Medicaid Services (”CMS”).
To consistently evaluate each claim, CMS classifies them against a standard set of codes. Each code is associated with a specific payment amount, which can be used by CMS to calculate reimbursements to Motor BCI providers.
Under the Health Insurance Portability and Accountability Act (HIPAA), The American Medical Association and CMS maintain and distribute the Healthcare Common Procedure Coding System (”HCPCS”) Level I (commonly referred to as “CPT”) and Level II codes, respectively (CMS, 2022).
🔖 The alignment with CPT and HCPCS Level II codes grounds Motor BCIs in standard reimbursement schemes which is the only way to scale their (US) distribution to the populations of severely paralyzed.
Owing to its novelty, many of the relevant codes for Motor BCIs have not yet been established, and it is up to the manufacturers to request new ones (e.g. NeuroPace Announces New Category I CPT Code).
Navigating the complex coding systems to uncover reimbursement codes relevant to Motor BCIs is beyond the scope. However, one can find many relevant codes by observing medical devices with somewhat similar characteristics.
The only two fully implanted intracranial BCIs with chronic electrophysiological recordings in the market are NeuroPace’s Responsive Neurostimulator (“RNS”) and Medtronic’s Percept PC Deep Brain Stimulator (”DBS”) systems. Although not designed for motor impairments, they each record, analyze, store, and visualize brain data to responsively trigger a custom stimulation protocol, preventing symptoms of epilepsy and Parkinson’s disease, respectively.
Figure 3; Oliveira et al., 2023: “Application of machine learning towards adaptive deep brain stimulation using closed-loop control. In the top
panel, a list of challenges at different stages of DBS therapy implementation where ML methods can play an important role. The diagram represents a closed-loop feedback system for aDBS, based on LFPs sensing and electrophysiological biomarkers identification and interpretation.” Reprinted from Figure 1.
The first-generation Motor BCIs are not concerned with neurostimulation. Instead, they expect the User to control an external device. This outlook may change as approaches of reactivating one’s own muscles (demonstrated early by Bouton et al., 2016 on hand-related tasks and recently by Lorach et al, 2023 on walking tasks) and restoring haptic percepts (Greenspoon et al., 2023; Valle et al., 2024) reach clinical maturity. Only recently, Herring et al., (2023) managed to combine some of these approaches into a proof of concept bidirectional Motor BCI bypassing the injury. I talk more about it in Other Electronic Applications.
Unfortunately, even the ‘external device’ options remain limited as Motor BCI arm prostheses (mounted on an electric wheelchair) are expected to cost roughly $100k (McGimpsey and Bradford, 2017) and exoskeletons a whopping $250k (Limakatso, 2023, well beyond any justifiable cost-effectiveness ratio. I further review the robotic Motor BCI applications in Converging VR and Robotics.
Myoelectric prosthetic hands, like the Ability Hand from Psyionic, are bringing the cost down to $20–30k which approaches the rates reimbursable with existing HCPCS codes. As before, these codes can act as a proxy for the more sophisticated Motor BCI robotics.
Therefore, the prevailing Motor BCI application settles for control of a standard computer cursor to spell out letters or control a user interface. Here, the solution competes with AAC devices, such as eye-tracking, which offer Users similar functionality non-invasively. Again, their HCPCS codes can help approximate Motor BCI reimbursement options. For example, the Tobii Dynavox I-Series is the most popular eye-tracker among the ALS community and has an HCPCS code of E2510 (Tobii, n.a.)
Unfortunately, CMS often fails to cover indirect and ongoing costs, including the Motor-BCI-reduceable attendance care and lost wages. Patients must resort to alternative sources of funding, such as Social Security Disability Insurance, Supplemental Security Income, and charitable organizations (ALS Association, 2017).
363M to level the playing field
Beyond those with severe paralysis, WHO and UNICEF (2022) report a staggering 363 million individuals with mobility and communication difficulties. While these difficulties may result from other causes, paralysis is among the leading ones.
For instance, Armour et al. (2013), co-authored by the US Department of Health, found that 1.7% of the US population live with paralysis. Scaling the prevalence to the global population yields 136M individuals with paralysis which restricts their mobility.
“Stroke was the leading cause of paralysis, affecting 33.7% of those with paralysis, followed by SCI (27.3%), multiple sclerosis (18.6%), and cerebral palsy (8.3%).”
Further, 85% of these individuals are unemployed. Solutions that help them overcome their paralysis may lead to a monumental economic impact.
On the communication front, 97M individuals would benefit from AAC due to their struggles with expressing their thoughts verbally (Beukelman and Light, 2020).
First Generation Users
Unsurprisingly, those most impaired by paralysis also generate the highest costs of care. In a world where economic value outconcerns individual wellbeing, the 1 million LIS individuals are ‘lucky’ to be considered the first recipients of Motor BCIs by all who currently develop them (Presentation Materials, Export Controls for BCI Conference at the U.S Department of Commerce, 2023).
🔮 However, the larger 21 million segment of severely paralyzed also fails to perform most activities of daily living despite often preserving some speech and movement. Should a convincing application arise to minimize their suffering or costs, they too could find immediate benefit.
The remaining populations will have to ‘wait their turn’ as Motor BCIs mature. While many are uneasy with the idea of receiving a brain implant, this opinion may be highly motivated by the perceived risk of developing complications.
Part 2 of a series of unedited excerpts from uCat: Transcend the Limits of Body, Time, and Space by Sam Hosovsky*, Oliver Shetler, Luke Turner, and Cai Kinnaird. First published on Feb 29th, 2024, and licensed under CC BY-NC-SA 4.0.
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*Sam was the primary author of this excerpt.