Original article by Nancy Crotti for MassDevice.
Developed by neurologists at Baylor College of Medicine’s Eagleman Laboratory for Perception and Action, BrainCheck carries an FDA Class II Software as a Medical Device (SaMD) designation and can be used on a tablet or laptop in person or remotely, according to the Houston-based startup.
Unlike a formal neuropsychological evaluation, which can take months to schedule and last for hours, a BrainCheck test consists of interactive games that take 10 to 15 minutes and give the physician and patient an idea of what to do next, according to the company’s chief medical officer Dr. Reza Hosseini Ghomi. A neuropsychiatrist with practices in Washington State and Montana, Ghomi said the test is a diagnostic aid that may validate a patient’s suspicions about their cognitive impairment post-COVID.
BrainCheck takes a patient’s age into account and uses games that challenge memory, primary and complex attention, executive function, impulsivity and mental flexibility. “It’s not an intelligence test,” Ghomi said. “The point of this test is it pushes everyone to their limit.”
It may also help a physician develop a care plan and track a patient’s cognitive function over time to better understand the current and future effects of COVID and COVID-related treatments, according to rehabilitation specialists at New York’s Mount Sinai Health System.
Mount Sinai’s rehabilitation center had just started using BrainCheck for cognitive assessments of people who’d suffered strokes or concussions when patients with post-acute COVID syndrome started showing up, according to David Putrino, director of rehabilitation innovation at Mount Sinai.
About 80% of the 900 patients they’ve seen with persistent COVID symptoms reported cognitive issues that they referred to as brain fog or short-term memory issues, difficulties with speech, language and concentration, Putrino told Medical Design & Outsourcing. Because most of these patients were otherwise cognitively high-functioning, the rehab staff decided to test them using BrainCheck rather than performing a full neuropsychology evaluation.
“It gives us some additional information to work with, which is great,” Putrino said. “We can track change over time. We can evaluate things objectively and see if people are improving over time with the cognitive care plans that we are prescribing in collaboration with our neuropsychology team.”
BrainCheck is quick, objective and does not exhaust the patients, who can take the test at home, he added.
The Mount Sinai team started using BrainCheck on post-COVID patients about a month ago, so it’s too early to tell how they progress. They plan to re-test each patient after eight weeks of cognitive care.
“We don’t have pre-COVID values on these patients, but we are seeing — in particular cognitive domains such as short-term memory, executive function and concentration — we’re seeing dips in what we would expect of the normative population,” Putrino said. “So these people are underperforming to age-matched controls.”
The cognitive effects of post-COVID syndrome are also affecting these patients’ quality of life, observed Putrino, who is also an assistant professor of rehabilitation and human performance at Icahn School of Medicine at Mount Sinai.
“Currently, we are just engaged in clinical care,” Putrino said. “We’re trying to capture clinical outcomes in a highly rigorous and complete way so we can look back on the data and see if there’s any research learnings to be had.”
More than 400 clinical practices, including neurology, primary care, internal medicine and gerontology, have administered more than 150,000 BrainCheck assessments, according to the company. Other hospital systems, including Cleveland Clinic, MD Anderson and Johns Hopkins have also adopted the technology.
BrainCheck is evolving, as well. The company plans to add assessments of gaze, voice and coordination as digital biomarkers to generate information that complements its current tests and may provide other early signals of cognitive changes.
Medicare and private insurers cover the BrainCheck tests, according to Ghomi, who hopes they will gain traction with more primary care physicians and neuropsychologists who screen for Alzheimer’s disease. He also wants BrainCheck to help cognitive care evolve the way cancer care has since the 1970s, when chemotherapy was one-size-fits-all.
“That’s where dementia is going. That’s where cognition is going… the direction where I can say, ‘Here is how your cognition is different from what it was. And here are the things we should do and watch it get better right now,’” Ghomi said. “It really gives people an objective thing to watch.”