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| First in the world clinical trial is being funded by the Focused Ultrasound Surgery Foundation. |
Performed on February 25, 2011, the treatment marked the start of a first in the world clinical trial being funded by the Focused Ultrasound Surgery Foundation. The single-arm, non-randomized pilot study is being conducted at UVA and is expected to treat as many as 15 patients with ET under an FDA-approved protocol. Elias is the principal investigator.
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| From left to right, UVA study principal investigator W. Jeffrey Elias, M.D., InSightec R&D and Neuro Programs Director Eyal Zadicario and FUS Foundation Chairman Neal Kassell, M.D. pose with the investigational ExAblate Neuro System. |
During the MR-guided focused ultrasound procedure, pulses of focused ultrasound waves were directed through the patient’s scalp and skull to a precisely targeted spot in the thalamus – a region deep within the brain known to be an effective target for treating ET and other movement disorders. The patient received no anesthesia for the treatment and was able to provide feedback to Elias and his team after each sonication. Following the treatment, he walked out of the focused ultrasound suite reporting that the sonications were painless.
| "The patient had been unable to use his dominant hand – his right hand – for over a decade because it shook uncontrollably. When we completed treatment, his tremor was gone. In the recovery room, he used his right hand to fill a cup and drink from it without spilling, draw spirals, and even work on a crossword puzzle." – W. Jeffrey Elias, M.D., principal investigator. |
Per study protocol, the patient remained in the hospital overnight and returned home the next day. A follow-up visit a week later indicated that his right hand was functioning normally. Additional follow-up assessments will occur 30 and 90 days post treatment, and Elias is hopeful that the patient’s tremor will not return.
While excited about the dramatic outcome this first treatment, Elias cautions that it is only the initial step in a lengthy process. "We need to complete this study and other clinical trials successfully before this treatment is eligible for approval by the FDA and its counterparts in other countries," he notes.
Chairman of the Focused Ultrasound Surgery Foundation Neal Kassell, M.D. says the success of this study could lead to other new treatments. "By demonstrating that MR-guided focused ultrasound can safely and effectively treat tissue deep in the brain with great precision and accuracy, we will open the door for treating a variety of conditions such as Parkinson's disease, brain tumors, and epilepsy. Much work remains to be done, but the path is clear," he observes.
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Dr. Elias monitors sonications from work station.
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Kassell adds, "Because the brain poses more complex technical challenges than other organs, success in treating ET could advance the entire field of MR-guided focused ultrasound. This study will undoubtedly inspire researchers who are developing new focused ultrasound therapies for the liver, breast and prostate, which are less complicated to treat."
To advance clinical research for ET, the Foundation is funding a second pilot study at Sunnybrook Health Sciences Centre in Toronto. That clinical trial is scheduled to begin later this year under a Health Canada-approved protocol.
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"By demonstrating that MR-guided focused ultrasound can safely and effectively treat tissue deep in the brain with great precision and accuracy, we will open the door for treating a variety of conditions such as Parkinson's disease, tumors, and epilepsy." - Foundation Chairman Neal Kassell, M.D.
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Study details
Current treatment options for ET range from medication to surgery. In the U.S., medication therapy provides satisfactory symptom control for many of the 10 million people with ET. For patients who do not respond to medication, the surgical procedures of choice are stereotactic thalamotomy or deep brain stimulation of the ventralis intermedius nucleus of the thalamus.
The UVA study is the first step in determining if MR-guided focused ultrasound is a safe and effective treatment for ET and if it offers benefits beyond current surgical options. The study is enrolling patients who are 18 to 80 years old and have completed trials of at least two ET medications without success. Before and three months after treatment, participating patients are being assessed for general health, neurological status and tremor measurements. The study is also collecting data about any device/procedure-related side effects that occur during the follow-up period.
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View of treatment area from the
control room, with Eyal Zadicario at work station.
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During treatment, patients remain awake and do not receive anesthesia. They are positioned on the ExAblate Neuro, a system manufactured by InSightec, Ltd. that has a specially designed table with a helmet-like head unit containing phased array focused ultrasound transducers. The table is placed inside a high resolution MR scanner that provides imaging for precise targeting. The scanner also provides thermal feedback to confirm and control sonication temperatures. Treatments are completely noninvasive and do not involve ionizing radiation.
All study treatments are being performed at the state-of-the-art UVA Focused Ultrasound Center which was established under a partnership of UVA, the Commonwealth of Virginia, InSightec and the Focused Ultrasound Surgery Foundation.
Click here for study information posted on the National Institutes of Health website. Patient inquiries can be directed to UVA Neurosurgery Clinical Trials at 434-243-1435 or by emailing FUSbrain@virginia.edu
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