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Key Points Participants are now being enrolled in a US clinical trial of FUSMobile’s NeurolyserXR focused ultrasound device for the treatment of sacroiliitis.  The Foundation is funding this study.   The first few participants have been enrolled in a new clinical trial investigating the safety and efficacy of using FUSMobile’s NeurolyserXR focused ultrasound device for the treatment of low back pain due to sacroiliitis.  Caused by inflammation of the sacroiliac (SI) joint, sacroiliitis is a common cause of pain and stiffness in the buttocks or lower back. It affects up to 27% of people in the United States. The NeurolyserXR uses high-intensity focused ultrasound guided by x-ray fluoroscopy imaging to heat and destroy neural tissue. The device has been used to treat other causes of low back pain, but this is the first study testing its ability to ease SI joint pain.   The trial is being led by Lynn Kohan, MD, an anesthesiologist and division chief of the Pain Management Center at the University of Virginia (UVA). In all, 10 participants will undergo a single noninvasive focused ultrasound treatment.  Participants will be followed for two years after the procedure, and pain relief will be assessed based on the numerical rating scale (1-10) and reduction or change in analgesic or opiate usage. Researchers will also track the participants’ self-reported quality of life.   “SI joint pain is not uncommon and can contribute to significant pain and suffering,” explains Dr. Kohan. Long-lasting procedures to treat the pain can be invasive; thus, there is a great need for an effective procedure that can help patients. Focused ultrasound targeted therapy can treat patients suffering from this painful disorder without using multiple needles. Thus, we hope to find an effective and safe noninvasive treatment option that greatly alleviates pain and suffering.”    The Foundation is funding this clinical trial.   Arik Hananel, MD, FUSMobile’s CEO and co-founder said, “Here at FUSMobile, we feel fortunate and grateful to collaborate with Dr. Kohan, UVA, and the Focused Ultrasound Foundation in this research and provide any needed technical support with the goal of improving patients’ quality of life.”  This year, the device has earned the CE Mark in Europe and Health Canada approval for the treatment of lumbar zygapophyseal joint syndrome, or arthritic low back pain. The company has also completed patient enrollment in a larger, pivotal clinical trial for lumbar zygapophyseal joint syndrome at 10 sites in the US. Similar studies were conducted in Canada and Israel.  For Patients  If you are interested in learning more about this clinical trial at UVA, please contact Alexi Moruza at (434) 243-5676 or AM2JT@uvahealth.org. 

Key Points As a teenager, Anya developed debilitating obsessive-compulsive disorder symptoms that eventually led to suicidal ideation and treatment in an in-patient facility.   Now, thanks to focused ultrasound, her symptoms are under control and she is looking forward to exciting new milestones.   When Anya was in her late teens, she began noticing some new psychological symptoms.  “Initially, it was mostly rituals or behavioral quirks, and most people weren’t even aware I was struggling with them. I remember thinking that I needed to open my computer or unlock my phone at a specific time that was a multiple of five. I would also follow the traffic signals when I was walking, so I would switch sides of the street along with the signals. It honestly felt like a bit of a game at first.”  But when she was 21, Anya and her boyfriend of three years parted ways, leading to a sudden onset of obsessive-compulsive disorder (OCD) symptoms. Soon after that, she received her official diagnosis.    “My symptoms really escalated. The compulsive behaviors stopped abruptly, but instead I began to have intrusive thoughts and obsessions. I felt like I had a non-stop radio in my head that just wouldn’t quiet. I was getting a lot of earworms, or snippets of lyrics and music stuck in my head repeating over and over again all day long, which was really excruciating. I started to realize that music was everywhere. I couldn’t go into stores, and even photos could trigger the earworms. I never had a clear head space. I was constantly having really invasive, intrusive thoughts.”  Following her diagnosis, Anya tried many different medications and therapy to help ease her OCD symptoms. Unfortunately, none of these interventions seemed to help. Her symptoms made it challenging to maintain relationships, and she was dependent on her parents for daily tasks. She became depressed and even experienced suicidal ideation. She was eventually admitted to a hospital for in-patient psychiatric care.  “I first got a glimmer of hope when I learned from a fellow patient that medication and therapy were no longer the only treatment options; neuroscientists were experimenting with neuromodulation. He told me about transcranial magnetic stimulation (TMS), and I travelled to Seattle and Tel Aviv to try that treatment. Unfortunately, it did not help with my symptoms, but it made me open to the idea of an intervention that directly targeted the brain.”  Nearly two years after her diagnosis, Anya learned about and was approved for focused ultrasound treatment at Sunnybrook Health Sciences Centre in Toronto. Focused ultrasound is a noninvasive therapy that uses intersecting beams of ultrasound guided by real-time imaging to treat tissue deep in the body, or in Anya’s case, the brain. The therapy is cleared to treat 15 diseases in North America, including essential tremor, Parkinson’s disease symptoms, prostate cancer, liver tumors, and uterine fibroids. However, it is still experimental for OCD, so Anya took part in a clinical trial.   On the morning of her treatment in early 2019, Anya felt hopeful.   “I felt like I really had nothing to lose. At that point, I had been severely ill for more than two years, and it was a living hell. I was so desperate to get better that I wasn’t scared of the procedure itself. I was only scared of the possibility that it might not help.”  Before the treatment, nurses shaved Anya’s head because tiny air bubbles that can get trapped in hair would interfere with the ultrasound waves. She then went into an MRI machine that was outfitted with a helmet-like focused ultrasound device. Anya was awake during the treatment, and she was given a button that would allow her to stop the procedure at any time.  “I just remember thinking that this was my last hope, and I was determined not to stop the treatment. I did feel some pain during the sonications, but it was temporary.”   Following her treatment, Anya’s only noticeable side effects were some facial swelling and grogginess, but both resolved after a few days. More importantly, she experienced a significant reduction in her OCD symptoms.   “After the treatment, my OCD symptoms gradually started to improve. I think the turning point was in March, a couple of months after the procedure, when we received an invitation to a relative’s wedding in Los Angeles. To my parents’ surprise and delight, I said that I wanted to go. Before the treatment, it would have been completely unthinkable for me to want to travel to attend a social event, let alone one with a lot of music. In time, I also noticed that interventions that didn’t help before – like medications and cognitive behavioral therapy – were now a lot more helpful. My OCD has improved tremendously.”  Now, five years later, Anya does not consider herself cured from the disease, but she says it’s in remission.   “Every now and again, if I’m exhausted or stressed, I do get some flare-ups of earworms or intrusive thoughts, but it’s not nearly as debilitating as it was, and it passes a lot faster. The symptoms now are a lot more manageable and are not getting in the way of my life anymore the way they were before the focused ultrasound.”  Since focused ultrasound, Anya has been able to return to work, attend school, and travel.   “I have worked as a teacher for a few years, including throughout the pandemic, teaching French, English as a Second Language, and social science subjects. I also went back to school to complete a master’s degree and traveled to Budapest for an internship as part of the program. On that trip, I visited Zagreb, Vienna, and Prague.”   She reports she has noticed a change in her relationships with family and friends and is looking forward to a major milestone this fall.   “I have made new friends, and I met my now fiancé in 2020. We’re getting married in October. But most importantly, my recovery has made my parents and extended family so happy. It is a miracle, ...

The Foundation recently worked with Bloomberg Businessweek reporter Noah Buhayar on the article, “Surgeons Cut a Giant Tumor Out of my Head. Is There a Better Way?,” where he recounts learning of focused ultrasound and the Foundation during his personal journey with a benign brain tumor. Though not a candidate for focused ultrasound, Buhayar shares how close friend and Foundation supporter Ted Weschler introduced him to the technology and the “potential for a post-scalpel future in which high-frequency sound waves augment and advance treatments for more than 170 medical afflictions.” Weschler has called focused ultrasound “the best investment he’s ever made.” The article includes Buhayar’s first-hand account observing an essential tremor patient being treated with focused ultrasound at the University of Virginia. He goes onto share exciting research exploring the technology’s role in sonodynamic therapy, immunotherapy, and blood-brain barrier opening. Highlights are also included from interviews with Board member and best-selling author John Grisham, former FDA commissioner and Foundation Council member Dr. Andrew von Eschenbach, focused ultrasound pioneer Dr. Kullervo Hynynen, and many others in the field.Buhayar does a masterful job explaining the history and state of focused ultrasound, as well as the Foundation’s urgency in advancing the technology in the shortest time possible. We sincerely hope you’ll read and share this article widely.Click here to access the article without a Bloomberg account for a limited time.

The Focused Ultrasound Foundation was mentioned in an article highlighting a patient’s experience with sonodynamic therapy for glioblastoma.