A cutting-edge, head-mounted ultrasound device called Diadem has recently completed two successful human trials, offering a new solution for treating chronic pain and depression.
Developed by researchers at the University of Utah, the Diadem device is named after a jeweled headband traditionally worn by royalty. It is designed to resemble an intricate headphone-like band. It operates through a process known as neuromodulation, where ultrasonic frequencies are precisely directed to specific brain regions. In these trials, the Diadem focused on the anterior cingulate cortex, an area involved in both pain perception and emotional processing.
In the first trial, 20 individuals suffering from chronic pain underwent two treatment sessions with the Diadem following a functional MRI scan to pinpoint the brain regions responsible for their pain. Remarkably, 60% of participants experienced a reduction in pain by at least 33% immediately after treatment. In a separate trial involving 14 clinically depressed patients, 10 reported significant remission of their symptoms just one week after a single session with the device.
“We’ve been blown away by the positive results so far,” said Tom Riis, the lead author of the study and 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 not every participant experienced dramatic improvement, Riis emphasized the profound changes seen in those who did. “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.”
One study participant shared their experience with the Diadem treatment, saying, “I was walking around the grocery store and just felt so clear. I was wondering, is this what normal people feel like?”
Unlike other brain stimulation techniques that often require invasive procedures, such as implanting electrodes into the brain, Diadem offers a non-invasive alternative. The device’s breakthrough lies in its ability to overcome the challenges posed by the skull, which typically scatters signals and makes precise targeting difficult. Diadem is tuned to compensate for this scattering effect, allowing it to target brain regions with millimeter-level precision.
“Ultrasound-based approaches can reach millimeter-level precision,” Riis explained. “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.”
Encouraged by the promising results, Riis and his team are now preparing for Phase 3 clinical trials, to secure FDA approval to make Diadem available as a treatment option for 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 Kubanek.
“The potential for this technique to change, even save, people’s lives is becoming increasingly clear. 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,” Kubanek added.
The team’s study has been published in the journal Pain.
Sources: University of Utah via EurekAlert
