A head-mounted ultrasound device has now completed two human trials. One showed how the targeted sound waves could improve pain symptoms, while another revealed a marked improvement in depression symptoms after just one session.
The device, known as the Diadem, was created by researchers at the University of Utah. The name refers to a jeweled headband worn by sovereigns and indeed, it looks like an intricate headphone-like band. It works through a technique known as neuromodulation in which beams of ultrasonic frequencies are sent to targeted areas in the brain. In this case, the device was used to target the anterior cingulate cortex, a region known for, among other things, pain perception and emotional processing.
During the pain study, 20 people suffering from chronic pain each received two sessions with the Diadem after undergoing a functional MRI scan to precisely identify the regions in their brains responsible for the pain signaling. When the study was over, 60% of the patients felt at least a 33% reduction in pain immediately following treatment. In the other study, 14 clinically depressed patients were treated with the MRI and Diadem procedure and 10 reported remission one week later after just one session with the device.
“We’ve been blown away by the positive results so far,” said the paper’s lead author, Tom Riis, a postdoctoral researcher in the Department of Biomedical Engineering. “After just a single 40-minute stimulation session, patients are showing immediate, clinically substantial improvements in symptoms.”
“While it should be kept in mind that not every participant saw drastic improvement, in the ones that did the change could be quite remarkable,” he added. “For several, you could just see it in their eyes – coming out of the session, their mood and behavior were a total 180 from when they had walked in. They were noticeably at ease, less burdened, more present.”
While stimulating brain regions to improve a range of symptoms has been a strategy that is gaining strength as we continue to map our gray matter's electrical patterns, many techniques require implanting some kind of device or electrodes directly into the brain, such as Elon Musk's Neuralink device. That being said, we have seen a range of non-invasive brain stimulation strategies aimed at tackling everything from dementia to diminished motor skills.
Precision breakthrough
The breakthrough achieved with Diadem's non-invasive approach though, has to do with the way the device handles the skull.
Because our skulls are, on average, about a quarter-inch thick, it can be difficult to direct signals where they need to go inside the brain because all that bone simply knocks their trajectory off track. Diadem can be tuned to account for this scattering effect so much so that it can target very precise brain regions.
“Ultrasound-based approaches can reach millimeter-level precision,” Riis says. “The same way you can focus light through a magnifying glass, you can focus sound waves into a small, intense volume. So we can stimulate a region about the volume of a peanut anywhere we want within the brain.”
Participants wanted
Now Riis and his team are gearing up to take Diadem through Phase 3 clinical trials. If all goes well, the device will receive clearance from the Food and Drug Administration to be made available as a treatment option to the general public.
“The rapid onset of the pain symptom improvements as well as their sustained nature are intriguing, and open doors for applying these noninvasive treatments to the many patients who are resistant to current treatments,” said co-author professor Jan Kabanek.
Individuals suffering from chronic pain interested in participating in the Phase 3 trials are encouraged to reach out to Riis and his team by emailing diademclinicaltrials@gmail.com.
“The potential for this technique to change, even save, people’s lives is becoming increasingly clear,” Kubanek said. “We encourage those who are dealing with these conditions to join our upcoming study. It’s very important to us to get this potential treatment to those who need it as soon as possible.”
The team's study has been published in the journal Pain.
Sources: University of Utah via EurekAlert
