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Treatment planning is an important aspect of transcranial focused ultrasound procedures, and the capability to predict patient-specific heating of a target is not currently available clinically.
Neuropathic pain is a fairly common condition, affecting an estimated 7-10% of the population.
Taiwan-based EpiSonica has secured Taiwan Food & Drug Administration (TFDA) clearance of its ArcBlate MR-guided focused ultrasound system for soft tumor ablation of uterine fibroids, adenomyosis, and palliative pain care. ArcBlate can be used in any commercial MRI system.
More than 40 experts from around the world gathered for the Focused Ultrasound and Immunotherapy Summit, held in partnership with the Cancer Research Institute on October 14. The group met to critically evaluate the current body of evidence, assess the value of ongoing work, and create a roadmap of projects to address any remaining gaps or questions.
Nearly 200 researchers presented their data at the 5th International Symposium on Focused Ultrasound in August. The Symposium is the world's leading forum for sharing the latest translational and clinical advances in focused ultrasound – a groundbreaking non-invasive therapeutic technology. Targeted to scientists, clinicians, and other stakeholders, the conference offered a multifaceted exploration of this emerging field and feature plenary sessions, panel discussions, poster presentations and technical exhibits.
Read the event summary.
You can now view the video presentations and read the abstracts here.
The 20th International Congress of Parkinson's Disease and Movement Disorders was held June 19-23 in Berlin, Germany with more than 5,000 attendees. Seven focused ultrasound abstractswere presented, including the latest preliminary study data for Parkinson’s tremor and essential tremor.
In an editorial published in the Journal of the American Medical Association (JAMA), Drs. Hu, Laviana, and Sedrakyan suggest that new technologies should be used cautiously until rigorous scientific evidence of safety and efficacy is available. This position is fully endorsed by the Focused Ultrasound Foundation.
On July 11, 2016, the US Food and Drug Administration (FDA) approved focused ultrasound to treat essential tremor. Read the FDA's release below.
The U.S. Food and Drug Administration today approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro uses magnetic resonance (MR) images taken during the procedure to deliver focused ultrasound to destroy brain tissue in a tiny area thought to be responsible for causing tremors.
After battling breast cancer for 12 years, Cynthia received devasting news; the cancer had spread to her brain. That's when Cynthia and her family turned to a clinical trial investigating the use of focused ultrasound.
On January 24, we lost one of the giants of therapeutic ultrasound when Professor Floyd Dunn passed away at age 90.
Medical Device and Diagnostic Industry (MD+DI) recently listed focused ultrasound as one of its top five technologies to watch in 2015.
FORTUNE has published two fantastic articles about the potential of focused ultrasound.
A new InSightec study to determine feasibility and safety of using the ExAblate System to treat localized, low-risk prostate cancer has begun in California. Jeffrey Wong, MD, Professor and Chair of the Department of Radiation Oncology and Associate Director of the Prostate Cancer program at City of Hope in Duarte, California is the principle investigator at City of Hope. The study will begin enrolling at the Mayo Clinic in Rochester, Minnesota, and other locations. City of Hope is the first U.S. site to treat a patient enrolled in this study.
Patients who are interested in this study, should contact Maria Brooks at City of Hope (626) 256-4673 ext 64402,
As reported in the current issue of Nature Neuroscience, scientists on Dr. William J. Tyler’s research team at Virginia Tech were interested in using focused ultrasound to noninvasively modify human brain function. They targeted sensory areas of the brain and were surprised by their findings: low-intensity focused ultrasound significantly improved function by decreasing impulses to the median nerve in the arm thereby enhancing the patients’ ability to discriminate between different kinds of stimulation. Secondly, they were impressed that the focused ultrasound could target smaller, more specific areas in the brain as compared to other neuromodulation technologies.
Focused ultrasound treatment for Parkinson's disease was featured as the cover story in the December issue of Practical Neurology.
The article consisted of a Q&A with Dr. Binit B. Shah, MD, Assistant Professor, Neurology, Parkinson's Disease and Movement Disorders Division at University of Virginia.
Radiology Today magazine featured a balanced article detailing the uses of focused ultrasound to treat a wide variety of disorders such as uterine fibroids, bone mets pain, essential tremor, Parkinson's disease, and more.
Kona Medical’s two ongoing WAVE studies demonstrated the ability of focused ultrasound to noninvasively reduce blood pressure in patients with drug-resistant hypertension. Renal nerve ablation with their focused ultrasound—based Surround Sound™ Renal Denervation System produced clinically significant drops in both systolic and diastolic blood pressure. For the combined studies, 73% of patients experienced a clinically significant drop in systolic blood pressure of 10 mmHg or more at three months and 81% at six months with no device-related serious adverse events. As impressive as the drop in blood pressure, the WAVE II study also uses a dosing pattern that reduced therapy time from 13 minutes to 3 minutes.
As a true testament to the potential of focused ultrasound to change medicine, TWO out of 15 companies selected by Fierce Medical for their top 15 innovators of the year are focused ultrasound companies: InSightec and Kona Medical.
An article in Dotmed daily news, an online site which follows medical devices and the industry, featured this story on the use of focused ultrasound to treat brain disorders like essential tremor, OCD, and Parkinson's disease:
Good overview article about some of the many applications of therapuetic ultrasound from Dotmed.com Daily News, an online journal about medical devices and technology.
AANS PRESS RELEASE Embargoed until April 29, 2013, 2:30 p.m. CDTContact:John A. IwanskiDirector of Member and Public Outreach(847) 378-0517 |
Subjects of Phase I Study of Transcranial MR-guided Focused Ultrasound Thalamotomy See Reduced Tremor,Improved Quality of Life
NEW ORLEANS (April 29, 2013) — Research findings offered today during the 81st American Association ofNeurological Surgeons (AANS) Annual Scientific Meeting show that the use of transcranial MR-guided focused ultrasoundfor producing a thalamotomy can have significant positive effects on subjects suffering from essential tremor.
TIRAT CARMEL, Israel, Apr. 18, 2013 – InSightec Ltd. announced today that the US Centers for Medicare & Medicaid Services (CMS), a federal agency within the US Department of Health and Human Services (HHS), has created a new billing code for MR guided focused ultrasound treatment of pain palliation of metastatic bone lesions and has established a Medicare payment rate for hospital outpatient departments.
U.S. start-up HistoSonics, Inc. is preparing to launch clinical trials using its noninvasive pulsed ultrasound technology to treat benign prostatic hyperplasia (BPH), an age-related condition that, over time, affects nearly all men. Estimates indicate that 50% of men over 50 and 80% of men over 80 have BPH. More than two million Americans have the condition and about 400,000 are treated surgically for BPH each year.
Executives of EDAP and SonaCare Medical – two focused ultrasound device makers that are engaged in commercialization activities – say healthcare trends are creating a unique opportunity for their companies and for men with localized prostate cancer.
On Monday, March 25, 2013, Canadian TV (CTV) broadcast a follow-up report about Tony Lightfoot, a man who had been severely debilitated by essential tremor for more than a decade. He was the fourth patient treated in the Focused Ultrasound Foundation-funded Essential Tremor Pilot Study at Sunnybrook Health Sciences Centre in Toronto.
Update from Jessica L. Foley, PhD, Scientific Director, Focused Ultrasound Foundation
FasterCures has launched Sequestration Station, an online destination for relevant and up-to-date news, resources, facts, and FAQs about how sequestration – or automatic government spending reductions - could impact medical research. These automatic spending cuts will take effect in January 2013 unless Congress acts soon.
The Journal of Gene Medicinehas e-published ahead of print a preclinical study about a novel gene delivery method and a novel strategy for treating liver tumors. A team of Chinese researchers report succeeded in inhibiting liver tumor growth and improving survival time by combining high intensity focused ultrasound ablation with ultrasound-targeted microbubbles loaded with the herpes simplex virus thymidine kinase gene.
InSightec, Ltd. announced today that its ExAblate MRI-guided Focused Ultrasound system has received FDA approval to treat pain associated with bone metastasis. This is the second FDA-approved use of the ExAblate, which gained regulatory approval in 2004 for the treatment of symptomatic treat uterine fibroids.
A cover article in The Journal of Applied Physics describes how a team of researchers at Penn State Materials Research Institute designed and computationally tested a device constructed of a manmade metamaterial that can manipulate a variety of sound waves. Expected to benefit almost all current sonic and ultrasonic applications, the invention could lead to more accurate and efficient high intensity focused ultrasound therapies.
The International Society for Therapeutic Ultrasound has completed arrangements to have the proceedings of its 2012 meeting in Heidelberg, Germany published online in an open access format by the American Institute of Physics. The Society is inviting everyone who delivered oral and poster presentations at the meeting to submit an extended abstract of up to six pages in length using the ISTU 2012 AIP template.
ISTU is building a website for registering and uploading papers, and will soon provide access information to 2012 presenters. The submission deadline is September 2, 2012.
US biotech Celsion, Inc. will design and conduct a clinical trial in partnership with Oxford University (UK) to evaluate the use of its heat-activated drug, Thermodox, and ultrasound-guided high intensity focused ultrasound in treating patients with metastatic liver cancer. Patient treatments are expected to begin later this year. The study is supported by the National Institute for Health Research Oxford Biomedical Research Centre. It will be conducted as a multi-disciplinary collaboration between Celsion, the Oxford University Institute of Biomedical Engineering and the Oxford University Hospitals NHS Trust.
HealthHub, a blog from Brigham & Women’s Hospital, recently profiled the institution’s National Center for Image-Guided Therapy. The blog acknowledged the center’s Co-Principal Investigators Ferenc Jolesz, MD and Clare Tempany, MD for their pioneering work in MR-guided focused ultrasound. Also acknowledged was Nathan McDannold, PhD, leader of a research program that is studying focused ultrasound in treating brain tumors, chronic pain and tremors and in opening the blood-brain barrier to facilitate drug delivery. The center’s is also investigating focused ultrasound treatments for breast and bone tumors and cardiac arrhythmias. READ BLOG
Billy R. Williams is proud to be the first patient in the world to receive focused ultrasound treatment for essential tremor. A year after his procedure, which marked the beginning of the ground-breaking pilot clinical trial at the University of Virginia, he reports being "very, very happy" with treatment results. In a video interview, Williams and UVA neurological physical therapist Diane Huss, PhD, say that some tremor has returned but is being managed by a small and well-tolerated drug dose.
As Dennis Parker, PhD and his colleagues at the University of Utah continue to refine and advance their new HIFU system for breast tumors, they have also joined forces with Swiss and French researchers to solve the technical problems of measuring temperature changes during focused ultrasound treatments.
In designing their system, the Utah team has come up against significant technical challenges. For example, they had to determine how to measure temperature changes in fatty tissues, adjust for motion-related errors and cover larger volumes at acceptable spatial and temporal resolution. Their quest for solutions led to a collaboration with University of Geneva researchers who are addressing similar problems in developing a HIFU system for liver tumors. The Foundation supported this collaboration through a $100,000 Research Award for a project entitled, “Robust MR thermometry for MRgHIFU in breast and liver.” (Click here to read a previous newsletter report about that project.)
In its April 23, 2012 edition, the Boston Globe spotlighted the work being done at the University of Virginia and Brigham and Women's Hospital to advance focused ultrasound treatments for the brain. Click here to read the report, "Brain surgery that’s not invasive."
Executive Perspective: Falko Busse, PhD, Philips Healthcare
Asian markets are leading the adoption of focused ultrasound, reports Falko Busse, PhD, vice president and general manager of MR-HIFU for Philips Healthcare.
Executive perspective: Interview with Jacques Coumans, PhD (GE Healthcare)
MR-guided focused ultrasound has entered a crucial period in terms of adoption,says Jacques Coumans, PhD, general manager for premium and interventional MRI at GE Healthcare. The pressing challenge, he says, is to “cross the chasm to mainstream clinical use” by expanding the number of sites by tenfold.
Noting that there are now about 150 MR-guided focused ultrasound sites worldwide, Coumans explains, “We often call this the academic bolus range.” He says that more than 1,000 sites will be needed to achieve successful adoption of the technology.
Optimistic about the future, Coumans adds, “I would characterize the field of MR-guided focused ultrasound in the following way: in five years, we will all wake up stating that the overnight success of MR-guided focused ultrasound was 15 years in the making.”
Although the technology was pioneered primarily at the Brigham and Women’s Hospital in Boston more than a decade ago, the adoption of MR-guided focused ultrasound is happening faster outside of the United States. Coumans believes this trend is due to fewer regulatory and reimbursement hurdles in other countries.
“One of the big advantages of MR-guided focused ultrasound could be that the quality of care is significantly improved, but one of the hurdles that we see is the cost associated with it. Obviously, having an MR machine with a very expensive option called focused ultrasound increases the cost of a procedure. Certainly here in the west – in the United States, in particular – there are regulatory and reimbursement hurdles that are very significant and take a long time to sort out.”
There are also practical issues to address as more focused ultrasound therapies are introduced: who does the procedure and who owns the patient? Coumans foresees focused ultrasound expanding beyond radiology. The most likely users are oncologists and interventionists, he says.
Coumans has worked in the field of MRI since 1985 and has been following MR-guided focused ultrasound since its inception. GE supplies the MR scanner for InSightec’s ExAblate system, which has received CE-marking for treating uterine fibroids, adenomyosis and metastatic bone tumors. The system is also approved in the U.S. for the treatment of uterine fibroids.
“I think MR-guided focused ultrasound is an intellectually incredibly appealing combination of two modalities,” Coumans asserts. “The fact that you can [use it to] non-invasively treat and non-invasively deposit [drugs] is something that was not thought of 20 years ago. Non-invasive or minimally invasive therapies are the thing of the future, and patient centricity and humanizing radiology really stand in the forefront of why MR-guided focused ultrasound has this appeal for patients as well as for physicians.”
According to Coumans, “It’s not so much just the focus on focused ultrasound, it’s the focus on using MRI to guide therapy because of its extreme suitedness to get soft tissue contrast properly portrayed and to follow up treatments over time,” he explains.
Commenting on growing competition in the focused ultrasound marketplace, Coumans calls it a positive development. Intellectual competition, clinical case studies, multimodality and multicenter trials contribute to growth. “Any industry benefits from competition,” he notes. “We welcome it.” - Written by Ellen C., McKenna
At RSNA 2011, Jack Coumans talks about the MR Patient Experience Suite –
Yoav Medan, Chief Systems Architect of InSightec and Visiting Associate Professor, Biomedical Engineering at the Technion Institute of Technology, was interviewed for the Discovery Channel's online video content channel called Curiosity.Com in a series of videos about focused ultrasound.
Cancer Research Technology, the commercial arm of Cancer Research UK has spun off a private comapny called 'Acublate Limited' which will be developing a HIFU device used to treat various types of solid tumors. Initially, the Acublate device will treat patients with bowel cancer that has spread to the liver.
Dr Keith Blundy, CRT's CEO, said: "We're delighted to be able to take the research into this exciting technology that Cancer Research UK helped fund onto the next stage. The HIFU technology currently approved for clinical use in the UK specifically targets prostate cancer but we hope the Acublate device will be able to treat most solid tumour types."
Read the press release here:
The visibility of focused ultrasound is skyrocketing. TIME Magazine has named it one of the 50 most inspired ideas, innovations and revolutions of 2011. In its coverage, TIME heralds MR-imaging and focused ultrasound "remarkable in their own right"and observes that "something life-changing" emerges when the two are combined.
"Visiting the center was like taking a journey into the future of healthcare. Its an amazing facility, organized around the concept of personalized medicine. The therapeutic goal is to create a positive and memorable experience for the patient," Huff-Simonin says.
Opened in October 2010, the center was created by Kwang Yul Cha, MD, the founder and head of CHA Health Systems. CHA currently operates a global network of healthcare facilities that includes Hollywood Presbyterian Medical Center in Los Angeles, 12 general hospitals in Korea and two fertility treatment and anti-aging research centers in the US and Korea.
Celsion Corporation recently announced it is moving its headquarters from Columbia, MD to Princeton, NJ. An article published in yesterday’s Baltimore Sun asserts that the move is prompted by the lack of a labor pool in Maryland with experience in marketing, selling and distributing pharmaceuticals.
In addition to sponsoring clinical trials that are assessing its heat-sensitive drug, Thermodox, as a treatment for liver and breast cancer, Celsion is working in partnership with Philips Healthcare to develop a new focal drug delivery treatment for metastatic bone cancer. The method combines ThermoDox with Philips’ MR-guided focused ultrasound technology.
A story pitched and facilitated by the Focused Ultrasound Surgery Foundation was broadcast on the CBS Evening News on June 12, 2011.
Acknowledging that focused ultrasound could be one of the biggest medical advances since the scalpel, the report included interviews with uterine fibroid patient Stephanie Small and University of Virginia radiologist Alan Matsumoto, MD.
Richard J. Price, Ph.D. is investigating a novel combination of nanoparticles, microbubbles and focused ultrasound – a combination that he believes could effectively treat and possibly cure diseases of the central nervous system, including brain tumors, dementia and Parkinson’s disease.
During last month's meeting of the European Congress of Radiology in Vienna, Philips Healthcare announced that its Sonalleve MR-HIFU system has received CE Marking for palliative care of patients with bone metastases. Equivalent to FDA approval in the U.S., CE Marking is recognized by countries in the European Economic Area and signifies that a product complies with the essential requirements of relevant health, safety and environmental protection legislation.
The company acknowledged that it intends to seek similar approval in the U.S.
Philips has been marketing the Sonalleve for uterine fibroid treatment since December 2009 and has installed 22 systems worldwide. The Sonalleve system uses ultrasound energy to ablate metastatic tissue and sensitive nerves around the bone, alleviating the significant pain experienced by advanced cancer patients. The system's MR imaging provides 3D planning and temperature monitoring.
While most focal drug delivery research is still in the preclinical stage, the field's frontrunner, Celsion Corporation, has requested FDA permission to launch U.S. clinical trials of its investigational liposome-encapsulated drug, ThermoDox. Conducted in partnership with Philips Healthcare, those studies will investigate the use of ThermoDox in focused ultrasound-mediated drug delivery treatments for patients with metastatic bone cancer. Read more.
A promising new, noninvasive treatment for patients with essential tremor is making headlines this week. As announced yesterday in a Focused Ultrasound Surgery Foundation press release, a clinical trial at the University of Virginia has successfully used MR-guided focused ultrasound to treat its first patient - a man who had been unable to use his dominant right hand for more than a decade due to essential tremor. The focused ultrasound procedure completely stopped the man's tremor, and doctors are hopeful that it will not return. The treatment involved no anesthesia, incisions or ionizing radiation and targeted the thalamus, an area deep within the brain that has been associated with movement disorders.
The Focused Ultrasound Surgery Foundation is funding the UVA trial, which is being conducted under an FDA-aproved protocol and could treat as many as 15 patients. The Foundation is also funding a parallel clinical trial at Sunnybrook Health Sciences Centre in Toronto, which is scheduled to begin later in 2011 under a Health Canada-approved protocol. Click hereto read the Foundation's press release.
Graham Sommer, M.D., professor of radiology at Stanford University Medical Center, is opening up a new frontier in men's health for MR-guided focused ultrasound treatments. He and his colleagues at Stanford and the University of California, San Francisco have developed a device that uses this innovative, noninvasive technology to treat benign prostatic hyperplasia, or BPH. Click here to view video interview and read full report.
Vendor Update: InSightec, Ltd., Israel
InSightec reports that two new sites have joined its Phase 1 clinical trial assessing the ExAblate Prostate System and 14 patients with low-risk prostate cancer have now received treatment.
The newly added sites are the University of Rome in La Sapienza, Italy; and Jaslok Hospital in Mumbai, India. The other participating sites are the N.N. Petrov Research Institute of Oncology in Saint Petersburg, Russia and the National Cancer Centre at the Singapore General Hospital, Singapore.
Vendor update: Profound Medical, Inc., Canada
As many as 30 patients with early stage prostate cancer could be treated with a new, minimally-invasive device in a clinical trial expected to begin at two U.S. hospitals later this year, says Paul Chipperton, CEO of Profound Medical, Inc. (PMI). The Toronto-based venture is commercializing intellectual property and technology licensed from Sunnybrook Health Sciences Centre.
The January 24 issue of Aunt Minnie.com Ultrasound Insideroffers a link to a story about a MR-guided focused ultrasound system designed specifically for breast tumor ablation. Under development at the University of Utah School of Medicine in Salt Lake City, the system was the topic of a presentation given by Allison Payne, PhD, at the FUS Foundation’s 2nd International Symposium on MR-guided Focused Ultrasound in October 2010. Click hereto read the report, which was published by MedicalPhysicsWeb.com.
The FUS Foundation is one of the sponsors of the 4th Therapeutic Ultrasound School being held in Les Houches, France. Successor to the hugely successful schools in Oxford and Corsica, the program will explore the rapidly emerging field of therapeutic ultrasound. Topics will range from an introduction to the physics and biophysics necessary for understanding these techniques to clinical applications. Each topic will be covered by an invited speaker who is a world authority in the field.
For more information, visit the information page or download the flyer. Spaces are limited, so register early!
Last month, John Snell, Ph.D. (Technical Director of the FUS Foundation Brain Program) and I visited Sunnybrook Research Institute (SRI) in Toronto, ON. We had the pleasure of touring the incredible facilities there.
Kullervo Hynynen, Ph.D., Director of the Imaging Centre, showed us around the research space that houses the labs of nearly 20 faculty members doing imaging research. This space includes dedicated clinical, pre-clinical and laboratory areas for research in focused ultrasound. In addition, the Centre has manufacturing capabilities for transducer design and development. Thus, its staff can build solutions in-house and test them through the full translational process from design through pre-clinical and clinical testing.
The hardest part of his job, says Joo Ha Hwang, M.D., Ph.D., is informing patients that they have pancreatic cancer.
Hwang, a leading researcher in focused ultrasound and gastroenterologist at the University of Washington in Seattle, is troubled by the lack of effective treatments for this deadly disease. "For decades, we've been treating pancreatic cancer and coming up with one new drug regimen after another. Yet, nothing has made a dent in improving patient survival," he notes.
Preclinical studies using MR-guided focused ultrasound for targeted drug delivery have achieved promising results, and Hwang believes clinical trials could begin within the next two years. "The potential impact of focused ultrasound could be huge," he says. "It could completely change the paradigm for treating patients with pancreatic cancer."
Read more and view video>
As a noninvasive therapy for the extreme back pain of facet joint osteoarthritis, MR-guided focused ultrasound shows considerable promise, reports Even Weeks, M.D., a FUS Foundation funded fellow at St. Mary’s Hospital in London.
Weeks and his colleagues are conducting a prospective, non-randomized clinical trial to evaluate the safety and efficacy of Insightec’s ExAblate system as a therapeutic technique for facet joint pain. Their goal is to enroll 20 to 25 patients and to follow them for a year to assess adverse effects, pain levels and functional outcome measures.
Discussions about Comparative Effectiveness Research (CER) were not commonplace conversation just over a year ago, but as the Health Care Reform initiative has progressed, it seems that nearly every single day we hear something about CER. Just last week Medical Devices Today published a piece about the amount of NIH Comparative Effectiveness Research funding dollars committed solely to medical-device-focused CER in 2009, and the number was significant at $40 Million. While some of these monies were directed to the establishment of CER centers at different universities, the majority involved short-term (2 year) studies in CER with funding totals for each project approximately $500,000. These short-term projects were funded through the American Recovery and Reinvestment Act of 2009 as part of the economic stimulus package.
The 9th Annual International Society of Therapeutic Ultrasound (ISTU) met recently in Aix en Provence, France and featured 128 speakers, dozens of technical posters, and brought together hundreds of experts in the field of focused ultrasound research. The meeting, sponsored in part by the FUS Foundation, is the premier yearly conference highlighting the engineering and technical work done to allow focused ultrasound to treat a myriad of medical conditions. Particularly exciting was the number of young and talented investigators that are leading the wave of new advances and applications. Also exciting was the large presence of equipment manufacturers showcasing their latest advancements including Philips, InSightec, Siemens, Haifu, Supersonic Imagine, and Profound Medical.
Featured prominently at the meeting was the more established use of focused ultrasound in heating targeted areas of the body to destroy diseased tissue and the conference included the latest advances in using the technology to treat uterine fibroids, prostate cancer, breast cancer, brain tumors, and other diseases. One of the tumor types receiving particular attention this conference were liver tumors which require special techniques to pass the ultrasound beams through the rib cage and visualize and track the liver while in motion due to the patient’s respiration. In addition to the use of focused ultrasound to ablate diseased tissue non-invasively, there was more emphasis than ever on the non-thermal applications of focused ultrasound in areas such as targeted drug delivery and the disruption of clots found in stroke patients.
Some highlights of the ISTU meeting observed by members of the Foundation staff include the following:
Ten-patient functional neurosurgery feasibility study shows potential for treating brain disorders with MR-guided focused ultrasound
Eben Alexander III, M.D., and Rolf Taylor
A groundbreaking new study has paved the way for clinical studies on the noninvasive treatment of a broad spectrum of brain disorders including Parkinson's disease, epilepsy, stroke, and brain tumors.
A team at the University of Zürich, in Switzerland, has completed a pilot study using MR-guided focused ultrasound to treat 10 patients with neuropathic pain. The origin of pain in these patients included post-amputation phantom limb syndrome, nerve injury, stroke, trigeminal neuralgia, and post-herpetic neuralgia from shingles. The findings will be published in a forthcoming issue of Annals of Neurology.
The study was partially funded by the Focused Ultrasound Surgery Foundation, which funds translational and clinical research into new therapeutic applications of MR-guided focused ultrasound (MRgFUS).
The preliminary results in these patients are comparable to those obtained with conventional therapy – radiofrequency ablation – an invasive procedure that involves making an incision in the scalp, drilling a hole in the skull, inserting an electrode through normal brain tissue into the thalamus, and using radiofrequency electromagnetic waves to create the lesion.
Functional neurosurgery involves alteration of the brain’s circuitry to treat various neurological conditions such as pain, movement, and behavioral disorders. It is a growing discipline that has developed over more than 60 years. In general, treatment involves creating lesions (destruction) in a neural circuit using radiofrequency ablation, or placing an electronic deep brain stimulator (DBS) to modulate the activity of a circuit. Ablation has the advantage of treating the patient with a single procedure; however, it involves the risk of long-term neurological complications if the location of the lesion is suboptimal.
Use of DBS has the advantage of reversibility in the event of improper location, but is far more expensive in terms of monetary cost and the time spent by specialists programming and maintaining the stimulator and its power supply. In addition, both ablative lesions (commonly performed by inserting a radiofrequency electrode) and DBS involve electrode passage through the brain itself, with a significant risk of hemorrhage or infection. The latter is especially problematic in DBS placement for patients with Parkinson’s Disease, whose state of health and poor self-care result in four to seven times the risk of infection, compared to general neurosurgical patients.
Stereotactic radiosurgery (using the Gamma Knife or Linear Accelerator) has demonstrated a somewhat limited applicability as a noninvasive method in certain functional neurosurgical disorders, especially trigeminal neuralgia (a common type of facial pain). However, its use of high levels of ionizing radiation may lead to significant complications.
Focused ultrasound is the first truly noninvasive treatment approach to emerge as an alternative to surgery and radiation. By focusing thousands of ultrasound beams on a single point, the medical team can achieve the same therapeutic effect as radio frequency ablation and radiosurgery, but without the risks and complications associated with traditional surgery or ionizing radiation.
“This study showed that we can perform successful operations in the depths of the brain without opening the cranium or physically penetrating the brain with medical tools, something that appeared to be unimaginable only a few years ago,” says Daniel Jeanmonod M.D., a neurosurgeon at the University of Zürich and the study’s co-principal investigator.
“By eliminating any physical penetration into the brain, we hope to duplicate the therapeutic effects of invasive deep brain ablation without the side effects, and for a wider group of patients. The research funding from the Focused Ultrasound Surgery Foundation allowed us to conduct the study rapidly and with scientific rigor,” adds Dr Jeanmonod. “We are an academic institution and this type of award is essential to our research process.”
According to Neal Kassell, M.D., a neurosurgeon at the University of Virginia and chairman of the Focused Ultrasound Surgery Foundation, the key advantage of focused ultrasound is that it is noninvasive. This, in principle, makes it safer than conventional surgery by avoiding the associated risks of infection, hemorrhage, and damage to the brain.
“This research demonstrates that MR-guided focused ultrasound can be used noninvasively to produce small thermal ablations with extreme precision and accuracy deep in the brain,” explains Dr Kassell. “This lays the foundation for revolutionizing the treatment of a variety of brain disorders that traditionally required surgery, including Parkinson's disease and essential tremor, epilepsy, brain tumors, and stroke.”
“We are pleased to have been able to provide funding for this groundbreaking research,” adds Eben Alexander, M.D., director of the Brain Development Program at the Focused Ultrasound Surgery Foundation. “Dr. Jeanmonod’s work may help open the door to enable the noninvasive treatment of some of these most prevalent brain disorders.”
Other research sites are expected to initiate clinical studies on the use of MR-guided focused ultrasound for treating brain disorders within the next year.
The University Children’s Hospital in Zurich, Switzerland recently celebrated treating its tenth neurosurgery patient with focused ultrasound. The patient had suffered for almost ten years from neuropathic pain – pain that originated when a benign brain tumor damaged nerve fibers in his brain which led to extreme pain and cramping in his right arm.
The Christian Broadcasting Network (CBN) recently ran a feature on its telecast and web site about focused ultrasound surgery and the role of the FUS Foundation in accelerating the development and adoption of FUS technology.
Entitled "The Sonic Miracle," the piece highlights the exciting current uses of the technology and some of the revolutionary possibilities the future holds. Featured in the article are use of the InSightec ExAblate system by Dr. Suzanne LeBlange of University MRI in Boca Raton, the experiences of two patients being treated for uterine fibroids, and commentaries by Dr. Neal Kassell and Dr. Joy Polefrone of the FUS Foundation and Pat Robertson of CBN.
This feature represents significant media exposure for focused ultrasound. The CBN is broadcast in 95 percent of US viewing markets and is seen daily by about 1 million viewers. In addition, 650,000 people view CBN's web site each month. The response of patients and clinicians to this feature has been overwhelming with scores calling and emailing for more information. The web site article and accompanying video can be seen on the CBN web site here
Prostate cancer: When will we have a reliable prostate cancer screening system for men, and when we do, how will we treat those many cases of early-stage prostate cancer that are detected?
Are we inching closer to a “ManoGram”? Rolf Taylor contemplates the current landscape – and the potential for increased research funding in the near future.
1 in 6 men will face prostate cancer in their lifetime, and each year it will kill 28,000 men in the U.S. alone. But unlike breast cancer, for which outcomes have improved dramatically as a result of near universal mammograms and advances in treatment options, prostate cancer remains stubbornly under diagnosed. Patients with rising PSA levels who show signs of malignancy don’t want to risk doing nothing, but can’t be sure that they definitely need treatment. And surgery carries major risks including erectile dysfunction and incontinence. Many patients need a blood transfusion during surgery.