Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that affects muscle control, and most patients reach a point at which either the disease itself or a necessary tracheotomy impair their speech. Because eye movement is typically preserved longer, assistive technologies that track patients’ gaze have helped them communicate, but even control of eye movement can eventually be lost. This leaves patients in a form of “locked-in syndrome” with no means of communicating with their loved ones and caregivers, sometimes for more than a year at the end of their lives.
But maybe it doesn’t have to be that way. The brain-computer interface (BCI) company Cognixion today announced a clinical trial investigating the use of its Axon-R headset as a communicative device for patients in the late stages of ALS, also known as Lou Gehrig’s disease. The company hopes to provide a communication tool to a group of people with no proven alternatives.
“We’re trying to solve the hardest problem we can find,” says Chris Ullrich, chief technology officer at Cognixion. Using the headset for this application requires combining BCI tech with both artificial intelligence and augmented reality.
How Cognixion’s BCI tech works
The non-invasive headset monitors brain activity with electrodes placed over the occipital lobe at the back of the skull. These electrodes use the standard brain-monitoring technique of electroencephalography( EEG) to detect a signal known as steady state visual evoked potentials (SSVEP), a natural brain reaction to an image flashing at regular intervals, perhaps 8 to 15 times per second.
The Axon-R device can detect a choice among multiple options (such as different letters, words, or phrases) presented at different frequencies within the user’s augmented reality view. The device can offer up groups of letters for the user to chose between and then offer the individual letters within that group; like a smartphone’s autocomplete function, it can also suggest likely words or phrases based on the user’s initial choices.
The resulting message can be read aloud automatically or can be displayed on a front-facing screen next to the patient’s face. Critically for late-stage ALS patients, the brain response is triggered through attention alone, and doesn’t require the user to directly gaze at the option they want to select, says Ullrich.
Cognixion has also developed an assistive AI system, which it dubs a “conversational co-pilot,” to help patients produce speech more quickly. The AI will be tailored to each patient, trained on available examples of their own speech or writing, and will ideally be able to respond to a message with the suggestion of entire phrases or sentences after the user makes a few initial decisions. The company anticipates this will allow communication at “near conversational speed.”
What are the goals of the ALS trial?
“[Conversational speed] has been the holy grail of a lot of BCI research,” says Brendan Allison, a researcher affiliated with the University of California, San Diego and the BCI Society, who does not work with Cognixion. But generally, the fastest claimed performances (measured in words per minute) have required a controlled laboratory setting, and sometimes restrictions on vocabulary.
Ullrich says that while Cognixion plans to track words per minute, this research will prioritize the rate at which patients make VEP-based selections, as well as the subjective experience of the patients and caretakers in dialogue.
Allison notes that success in this field is highly relative. “If you have someone who is at zero words per minute, [communicating at] even one word per minute—that’s huge,” he says. While naturalistic communication would be a remarkable achievement, for late stage ALS patients, any communication at all would be a boon. Patients using assistive communication are often involved in vital choices about their care and end-of-life decisions, and the reliability of these systems—at any speed—will be a key factor in ethical and legal matters.
The ALS patient and clinical trial participant Rabbi Yitzi Hurwitz tries out Cognixion’s communication tool.Cognixion
Other applications for Cognixion’s BCI tech
ALS affects somewhere on the order of 30,000 people in the United States, with about 5,000 new diagnoses each year, according to the U.S. Centers for Disease Control and Prevention. The Cognixion study is currently recruiting participants with the help of the ALS Association.
The Axon-R, with tools and feedback for developers, is a research version of the Cognixion One headset, which in 2023 received a breakthrough device designation from the FDA, a program intended to help streamline approval processes for medical devices addressing unmet needs. Cognixion currently sells the Axon-R as a research platform starting at US $25,000. An eventual consumer model Cognixion One would not require all of the same features, but pricing is yet to be determined.
Ullrich notes that the company’s technology, as a versatile platform for communication and control, could potentially also be useful to ALS patients at earlier stages of the disease, as well as people with other conditions that affect mobility or communication, such as cerebral palsy, multiple sclerosis, or spinal cord injury.
Another major approach to BCI-assisted speech uses implanted electrodes and records signals from parts of the brain associated with producing speech. More broadly, BCI technologies are being investigated for a variety of uses, such as control of a wheelchair or robotic prosthetics; gaming and entertainment; and general monitoring of brain health and activity.
