Democratizing brain-health assessment

For this eye-for-innovation story, I sat with Scott Anderson, chief clinical officer at SyncThink (now NeuroSync) — an expanding Palo-Alto tech company that has recently launched the third generation of its brain health and performance platform, EYE-SYNC® on the Pico Neo 2 Eye VR headset.

Scott is bright, humble, and passionate about what he does. I think it must be that deep sense of pride that people develop when working with innovation, debunking old theories, and delivering new insights that have the potential to raise quality-of-life for millions of people. And while the pandemic has prevented us from sitting in the same room, Scott’s sense of purpose is palpable even over video.

This post tells the story of the people behind the research, the decades of dedication to the demystification of brain health, and how today's commercially available VR hardware, together with Tobii's advanced eye tracking filters, meet the technical requirements that will enable SyncThink to scale.

The challenge of assessing brain health

Every year, an estimated 3.5 million people in the US sustain a traumatic brain injury (TBI), resulting in about 50,000 deaths. Today, some 5.3 million people in the US live with a permanent TBI-related disability. Apart from the cost and strain on healthcare systems, cognitive impairments resulting from a fall or an accident can change a person's life — profoundly affecting their ability to work and participate in daily activities. SyncThink was born out of research that aims to change this through improved understanding of TBI, with enhanced detection and judicious treatment capabilities.

The first generation of EYE-SYNC, launched back in 2017, was the culmination of over a decade of research and development. The work underpinning SyncThink's proprietary algorithms and IP began back in earnest in the early 2000s by the company's founder, Dr. Jam Ghajar — a well-known neurosurgeon at Weill Cornell in New York City. Ghajar was already an authority in his field at the time, having started the non-profit Brain Trauma Foundation (BTF) years prior. Without him and the evidence-based work of the BTF, it's unlikely that today's clinical care guidelines governing the detection and treatment of severe TBI would exist.

As Scott explained to me, TBI-related issues run much deeper than diagnosis and treatment of the initial trauma. The prescribed treatment for head trauma was traditionally a dark room. Patients were told to go home and wait for their symptoms to clear. But because of the BTF, Ghajar's revolutionary research, and the work he and Scott did together in their days together at Stanford, we now know that the former lack of understanding of the brain led to massive patient mismanagement. But that's not the worst part. And if you have a clinical background, what Scott explained to me is probably obvious. Like any other health problem such as a broken bone or pneumonia, a person who has suffered brain trauma needs to be assessed immediately, diagnosed properly, and prescribed an appropriate treatment plan. Left untreated, a broken bone often leads to additional complications, and it's the same for brain trauma. Without proper diagnosis and treatment, TBI patients risk developing secondary issues such as depression or migraine — especially people with a family history of such conditions — even if they recover from the initial trauma.

Quantifying brain function

As he dug deeper into understanding mild TBI, Ghajar became determined to find a way to accurately measure brain state activity following a cognitive disruption. He knew that an objective measurement was the key to unlocking the puzzle to achieve better patient outcomes.

During this time, the wars in Afghanistan were ongoing, resulting in a dramatic rise in exposure and complications from TBI among servicemen and women. As a result, the US Department of Defense began looking for a way to better identify cognitive deficits from TBI and improve care for soldiers returning from duty with lingering traumas such as PTSD, chronic neurological issues, and substance abuse — traumas that were going unreported and undetected.

The kinds of traumas that frontline soldiers deal with are often blast-related. Typical symptoms, such as headaches, dizziness, and reduced cognitive capabilities, often result in a persistent brain fog that negatively impacts decision-making and combat readiness. Ghajar hypothesized that eye movement variability would increase in soldiers subjected to TBI, and so measuring that would produce a reliable output that could confirm changes to brain state function. To assess his theory, Ghajar developed a circular smooth-pursuit test. In his test, the target moves slowly in a circle. The closer the subject maintains eye position with the target as it moves, the less eye movement variability occurs.

Pursuit tests are significant because of how human attention, processing, and working memory naturally rely on vision to make predictions about events that are about to occur. If a person cannot follow the relatively slow-moving target, it's clear they have cognitive impairments that can be related to trauma. Pursuits and saccadic tests also help to differentiate between different areas of the brain’s neural networks that are impacted by trauma. Crucially, however, you cannot measure how well a person follows a target through manual observation. So Ghajar designed the first kind of VR eye tracking system — a large clamshell device — that he used to test soldiers for impairment before deployment and again when they returned. And while that was a good start because it helped diagnose people who may have otherwise slipped under the radar, the testing did not distinguish between brain trauma and other common military conditions like ADHD, sleep deprivation, or substance abuse. And neither did it solve the issue of diagnosis at the point of need — on the battlefield.

And so, when Facebook released the second Oculus Developer Kit in 2012, Ghajar created the forerunner to EYE-SYNC. He ran the diagnostic algorithms on the Oculus headset and connected it to a tablet device so that military medics could conduct tests in the field. The whole unit was lightweight and portable enough to ship to the frontline. Predictably, however, once deployed to the middle east none of the equipment ever returned to the US.

Throughout these years of testing and development, Ghajar uncovered the keys to today's quantification of brain trauma. What he discovered was that eye movements are an exceptionally reliable metric for understanding changes in brain activity. He uncovered the correlation he was looking for: a unique and distinctive biomarker for impairment that commonly occurs after concussion which was separate and uniquely different from other biomarkers related to conditions like ADHD, sleep deprivation, and substance use — all based on eye movement.

Dr. Ghajar, Scott, and the birth of SyncThink

In 2015, Ghajar moved to Stanford University, and that's where he first met Scott, who was running the sports medicine program.

Scott recalls, on his third day, Dr. Ghajar came into my office, wanting to know if I was the guy in charge of multidisciplinary research. He wanted to know because he needed access to our athlete population to do some studies with a technology he had been working on with the military.

He told me, 'We're in the middle of clinical trials right now, and we're trying to validate with soldiers, civilians, and athletes. We need a broader population because we need to test 10,000 people.' At the time, I hadn't heard about his research. But as a clinician, I had treated people with neurological problems, so I was naturally intrigued. I subsequently joined the clinical trial team and began enrolling Stanford University athletes to validate the technology. After the completion of the clinical trials, we received the first FDA clearance and migrated the solution to the Samsung Gear VR (second generation of EYE-SYNC).

Unfortunately, the Samsung headset lacked the native eye tracking needed to measure eye movements. Scott’s colleague Daniel Beeler (CTO) points out in his 2018 blog post Behind an FDA clearance, eye tracking wasn’t commoditized for mobile VR solutions back then, so SyncThink built their own technology. He says, “It is not particularly difficult to make an eye tracker, but it is exceedingly difficult to make an eye tracker that works well across all populations.” To get solutions into the hands of their customers, SyncThink had to first ship their eye tracking implementation to a supplier in Germany who modified the Samsung device with the necessary sensors. This time-consuming and costly process essentially prevented them from scaling beyond early adopters.

There were a lot of issues with the solution, most of them related to the hardware and the administrative process associated with deploying new software releases. From what I can tell, SyncThink was a software solution waiting for the perfect hardware to come along, hardware that needed to meet several criteria.

• A VR headset natively equipped with accurate eye tracking to record detailed eye movements.

• A standalone headset that could function for several hours on a battery to ensure mobility.

• A commercially available headset at the right price point to enable mass-market capabilities such as shipping to sports arenas, clinics, and hospital environments.

• A comfortable, lightweight device that patients can wear for up to an hour without slippage or discomfort.

• High-level filters to remove the grunt work of transforming raw eye tracking data into reliable biomarkers.

The Pico Neo 2 Eye, released in early 2020 and equipped with Tobii eye tracking technology, meets requirements 1-4. The final point is satisfied by Tobii Ocumen, a middleware extension to Tobii eye tracking that delivers advanced real-time data streams and flexible filtering options, such as gaze vector on a per-eye basis and pupil diameter biomarkers.

With this third generation of EYE-SYNC, SyncThink is on the brink of expanded commercialization. Partnering with Pico and Tobii provides them with the freedom to focus on developing their proprietary solutions while we take care of the hardware and ensuring they get accurate and reliable measurements for everyone, everywhere.

Regulatory approval, the significance of VR, and data

Before I wrap up, I would like to add a couple of sidebars to this post. The first one relates to the regulatory process behind the EYE-SYNC Pico Neo 2 Eye. To support SyncThink’s documentation process in determining product equivalency, Tobii provided supporting information to show equivalence for the accuracy, precision, and robustness of the data generated by our eye tracking hardware and high-level filters. My second sidebar relates to the choice of VR as a technology. Some of the tests used in brain health assessment could run on a tablet device equipped with eye tracking. However, the benefit of VR, especially in noisy, crowded environments, is the ability to remove the influence of surroundings on a patient, resulting in a more accurate assessment. And my final note is about the data. Digitizing assessment in the way SyncThink has done generates tons of data — data that can be analyzed to reveal new insights about brain health and the effectiveness of treatment.

To wrap up, I would like to extend my gratitude to Scott for taking the time to talk. But most of all, for making this innovative technology possible. I look forward to the day that sports arenas, Little League fields, ice rinks, and football pitches are equipped with SyncThink's solution as well as clinics, field hospitals, and ERs. Who knows, one day, we may even be using this technology at home — and that would surely be healthcare democratization in action.

If you want to know more about EYE-SYNC, watch the video below.