Swedish Neuroscience Institute seeks participants for trial of new technology to treat essential tremor

One of only four sites in U.S. with promising FDA-approved technology to treat neurological disorder
Oct 03, 2013

Swedish Neuroscience Institute (SNI) is looking for patients willing to participate in a study of a promising new technology to treat essential tremor, a common neurological disorder, with sound rather than surgery.

Already approved in Europe, focused ultrasound treatment for essential tremor was shown to be effective in the U.S. in a yearlong study of 15 patients at the University of Virginia.

The study results were published in August in the New England Journal of Medicine. One of the study authors, Dr. Stephen Monteith, has been recruited to work at SNI and is helping lead the local study.

An estimated 10 million people in the U.S have essential tremor (ET), which causes a rhythmic shaking or trembling of hands and arms but can also affect the head, legs and other parts of the body.

It affects one out of every 25 adults over 40 and can be confused with but is different from better-known Parkinson’s disease, which is actually much less prevalent.

ET produces disabilities that hamper basic daily activities and worsens over time, with severely affected patients unable to feed or care for themselves.

“It’s all about quality of life and things that actually matter to people – eating, dressing, going to the bathroom,” Dr. Monteith said.

“Tremor can make it impossible to drink a glass of water or cup of coffee, write a letter and do many other things most of us take for granted.

“But we’ve seen all that come back with this treatment. People are gaining their independence again.”

The first patient already approved to participate in the study will be treated Oct. 4.

SNI hopes to have up to 10 patients successfully complete FDA-required screening to participate.

Adults who have been diagnosed with ET and want to participate should contact the neuroscience research department at 206-320-3070.

SNI is one of only four sites in the U.S. with the technology and approved by the FDA to participate in the next phase of the trial.

The InSightec ExAblate Neuro, developed by an Israel-based company, is a $1.5 million system that was installed at Swedish’s Cherry Hill campus this spring.

It transforms sound wave energy into heat and is used to focus 1,000 individual beams of sound onto a specific site on the thalamus, a part of the brain, to dramatically reduce the symptoms of ET.

Every one of the 15 patients in the University of Virginia study showed significant and sustained improvement in reduced tremor, Monteith said. ET can occur at any age but is most common in people 40 and older.

Dr. Ryder Gwinn, the principle investigator for the study at SNI who has utilized other treatments for patients with essential tremor, said focused ultrasound could be the best answer for many of these patients. For example, medication has been shown to be ineffective for up to half of all ET patients.

Dr. Gwinn said other methods of treating ET include gamma knife surgery, which uses radiation and can have significant side effects, and deep brain stimulation, which involves drilling a hole in the skull to place an electrode in the brain that operates similar to a pacemaker for the heart.

The advantages of noninvasive focused ultrasound include avoidance of radiation and invasive surgery that could result in infection, and a faster and potentially better outcome.

Patients stay awake throughout the one-time ultrasound procedure, and the positive results were apparent right away for patients in the first phase of the study.

Dr. David Newell, Chief of Neurosciences at SNI, said focused ultrasound for essential tremor is one of three new ultrasound technologies and treatments being tested at SNI.

The second utilizes technology developed by a company in Bothell for treatment of stroke caused by a blood clot originating in the heart or neck, and the third uses technology developed by a Redmond company to treat stroke caused by cerebral hemorrhage.

It’s no accident that two of three ultrasound technologies being tested are from local firms.

“Seattle is the largest cluster of medical ultrasound research and commercialization in the world,” Newell said.

“Our region was at the forefront in the development of sonar and submarines. That brought a lot of scientists here and ultimately produced a lot of medical spinoff companies.

“For years ultrasound in medicine was only for diagnostics. But now we have three applications in the neurosciences for treatment, and SNI is the only place in the world that is testing all three.”

SNI is also planning upcoming trials of ultrasound for treatment of epilepsy, Parkinson’s, brain tumors and other neurological disorders and diseases.

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