CHRONIC PAIN: UTRASOUND MAY BE A  TREATMENT

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Pain is a necessary biological signal, but various conditions can cause these signals to become distorted. For people with chronic pain, the root is often faulty signals emerging deep within the brain, giving false alarms about a wound that has since healed, a limb that has since been amputated, or other intricate, hard-to-explain scenarios.

Patients with this kind of life-altering pain are constantly looking for new treatment options; now, a new device from the University of Utah may represent a practical, long-sought solution.

Researchers at the university's John and Marcia Price College of Engineering and Spencer Fox Eccles School of Medicine have published promising findings about an experimental therapy that has relieved many participants after a single treatment session. They are now recruiting participants for a final round of trials.

Diadem, a new biomedical device at the core of this research, uses ultrasound to noninvasively stimulate deep brain regions, potentially disrupting the faulty signals that lead to chronic pain.

The findings from a recent clinical trial are published in the journal Pain. This study builds upon two previous studies, published in Nature Communications Engineering and IEEE Transactions on Biomedical Engineering, which describe the device's unique features and characteristics and demonstrate its efficacy.

The study was conducted by Jan Kubanek, a professor in Price's Department of Biomedical Engineering, and Thomas Riis, a postdoctoral researcher in his lab. They collaborated with Akiko Okifuji, a professor of Anesthesiology in the School of Medicine, Daniel Feldman, a graduate student in the departments of Biomedical Engineering and Psychiatry, and laboratory technician Adam Losser.

The randomized sham-controlled study recruited 20 participants with chronic pain. Each participant experienced two 40-minute sessions with Diadem, receiving natural or sham ultrasound stimulation. Patients described their pain a day and a week after their sessions, with 60% of the experimental group receiving actual treatment reporting a clinically meaningful reduction in symptoms at both points.

"We were not expecting such strong and immediate effects from only one treatment," Riis said.

"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," Kubanek added.

Diadem's approach is based on neuromodulation, a therapeutic technique that directly regulates the activity of specific brain circuits. Other neuromodulation approaches utilize electric currents and magnetic fields. Still, those methods cannot selectively reach the brain structure investigated in the researchers' recent trial: the anterior cingulate cortex.

After an initial functional MRI scan to map the target region, the researchers adjusted Diadem's ultrasound emitters to correct for the way the waves deflect off the skull and other brain structures. This procedure was published in Nature Communications Engineering.

The team is now preparing for a Phase 3 clinical trial, the final step before the Food and Drug Administration approves Diadem for general public use.

"If you or your relatives suffer from chronic pain that does not respond to treatments, please reach out to us; we need to recruit many participants so that these treatments can be approved for the general public," Kubanek said. "With your help, we think chronic pain can be effectively silenced. And with new pain treatment options, we can tackle the opioid crisis, too."

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