Treating the human brain has historically presented a challenge for researchers and clinicians. But digital health companies are increasingly using artificial intelligence, connected sensors and non-invasive devices to capture data on the brain and offer patient-specific treatments.
“This is a very critical time, because we've seen enormous advancements and are starting to see the benefit that technology can have in reading brain activity,” said Dr. Alvaro Pascual-Leone, director of the Berenson-Allen Center for Noninvasive Brain Stimulation at Boston-based Beth Israel Deaconess Medical Center.
By using technology, "we can address brain disabilities and detect problems earlier,” Pascual-Leone said.
Challenges in treatment
The brain can’t be studied like other organs, making diagnosis and treatment of neurological conditions particularly difficult, said Dr. Pravin Khemani, medical director of the movement disorders program at Seattle-based Swedish Neuroscience Institute. The brain's nature makes developing technology challenging—and potentially morally ambiguous, he said.
“The interface between machine and the human brain is still in its fledgling stages,” Khemani said. “It’s also governed by a lot of ethical issues. It’s difficult to implement technology that fundamentally changes who you are as a person.”
Researchers and clinicians have to rely more heavily on indirect evidence of how the brain works, compared with other organs, he said.
“We cannot put it in a Petri dish, dissect it and then put it back in someone's body,” Khemani said. “You can take pieces of other organs and examine them. You can’t necessarily do that with the brain.”
Like many other specialties, neurology also faces a clinician shortage. A study from December 2020 in the journal Neurology found that only 24% of people with a brain condition were seen by a neurologist over the course of one year.
Growth in the market
Although such hurdles can make creating tools more difficult, they also present use cases for the technology.
“If we actually want to help achieve the right level of access for these patients, we either have to churn out more neurologists somehow through our medical schools or we need technology to help improve access and make neurologists more efficient with their time,” said Elizabeth Burstein, CEO of the virtual neurology clinic Neura Health.
More developers are stepping up to the challenge. From 2010 to 2020, the number of clinical trials analyzing the use of digital health in neurology care grew at a compound annual growth rate of around 39%, according to a February study in npj Digital Medicine from researchers at University Hospital Düsseldorf in Germany, Beth Israel Deaconess Medical Center and Harvard Business School.
Ariel Stern, a co-author of the study and an associate professor of business administration at Harvard Business School, said a digital transformation has been taking hold in neurology research, especially when it comes to tools to track people’s motor skills, cognitive functions and sleeping patterns.
“It’s great that these tools are actually being studied and being used in formal clinical research. [It] means that we're actually going to learn about them … about their efficacy and what types of data they collect and the quality of [those] data, and what decisions can be made based upon [them],” Stern said. “This is a good thing for neurologists. It absolutely changes the paradigm.”
Pascual-Leone said different technologies can provide more precise readings on brain activity than analog methods, which could in turn help manage treatments more effectively than medication alone.
In addition to his position at Beth Israel Deaconess, Pascual-Leone is the co-founder of Linus Health, a digital health platform company that has developed an AI-enabled, digitized version of the Clock Drawing Test, a cognitive assessment used to detect dementia.
In a study published in July, researchers at Indiana University School of Medicine found that Linus' Food and Drug Administration-registered technology was able to outperform paper-based cognitive tests in detecting mild cognitive impairment and dementia.
"To understand the brain better, and in order to develop really precise, personalized interventions, we need technology,” Pascual-Leone said.
Many neurology tools still face regulatory hurdles, with the FDA clearance or approval process potentially taking years.
Neura Health only recommends treatments with significant evidence-based data backing them, Burstein said. She pointed to Cefaly, an FDA-cleared non-invasive device that’s used to treat serious migraines through external trigeminal nerve stimulation technology, as one example.
“It’s [a] high-impact space because we're dealing with the brain, real patients and the central motor of art of people's existence,” Burstein said.
But a regulatory-oriented approach won't necessarily be enough to persuade providers to prescribe the use of devices, said David Klein, CEO of Click Therapeutics. The company is developing prescription digital therapeutics applications to treat neurological disorders.
“We want to prove we have more robust evidence than even some of the drugs that are going into market,” Klein said.
Neurology innovations will also need to translate into clinical practice, Pascual-Leone said—meaning developers should work with doctors to create tools that address issues patients are facing.
“What we should be doing is delivering to people what matters to them,” Pascual-Leone said.