Engineers have created a device that stimulates deep regions of the brain without invasive procedures, potentially interrupting the incorrect signals that contribute to chronic pain. Initial tests indicate that this treatment can alleviate pain after just one session.
While pain serves as an essential biological indicator, various conditions can cause these signals to malfunction. For those suffering from chronic pain, the problem often lies in misleading signals arising from deep within the brain, which can misrepresent healed injuries or even amputation, among other complex and difficult-to-understand situations.
Individuals dealing with this debilitating type of pain constantly seek new treatment methods; a new device from the University of Utah could provide a practical solution that has long been pursued.
Researchers from the John and Marcia Price College of Engineering and the Spencer Fox Eccles School of Medicine have shared encouraging results regarding an experimental therapy that has yielded relief for many participants after just one treatment session. They are now in search of volunteers for the final phase of trials.
Central to this investigation is Diadem, a novel biomedical device that employs ultrasound to stimulate deep brain areas noninvasively, potentially interrupting the faulty signals associated with chronic pain.
The results of a recent clinical trial have been published in the journal Pain. This study is a continuation of two earlier studies featured in Nature Communications Engineering and IEEE Transactions on Biomedical Engineering, both of which detail the distinct features of the device and validate its effectiveness.
The study was led by Jan Kubanek, a professor at Price’s Department of Biomedical Engineering, alongside Thomas Riis, a postdoctoral researcher in his lab. They were joined by Akiko Okifuji, a professor of Anesthesiology in the School of Medicine, as well as Daniel Feldman, a graduate student in Biomedical Engineering and Psychiatry, and lab technician Adam Losser.
The randomized sham-controlled trial involved 20 chronic pain participants, each undergoing two sessions lasting 40 minutes with Diadem, receiving either real or sham ultrasound treatment. Participants reported their pain levels the following day and a week after the sessions, with 60% of those receiving actual treatment noting a clinically significant reduction in symptoms at both intervals.
“We were surprised by such strong and immediate effects from just one session,” said Riis.
“The quick improvement in pain symptoms, along with their lasting effect, is exciting and may broaden the use of these noninvasive treatments for patients who do not respond to conventional therapies,” Kubanek noted.
Diadem leverages a technique known as neuromodulation, which aims to directly influence the activity of specific brain circuits. While other neuromodulation methods utilize electrical currents and magnetic fields, these techniques cannot selectively target the anterior cingulate cortex, the brain area focused on in the recent study.
Initially, researchers performed a functional MRI scan to identify the target area, adjusting Diadem’s ultrasound emitters to account for how the sound waves reflected off the skull and surrounding brain structures. This methodology was documented in Nature Communications Engineering.
The research team is currently gearing up for a Phase 3 clinical trial, which is the last step prior to obtaining approval from the Food and Drug Administration to make Diadem available as a treatment for the public.
“If you or someone you know suffers from chronic pain that isn’t alleviated by traditional treatments, we encourage you to contact us; we need many volunteers to move forward with approval for these therapies,” Kubanek stated. “With your assistance, we believe we can significantly reduce chronic pain, and by introducing new pain management options, we can also address the opioid crisis.”
