Published on the website of the NORTHWEST PARKINSON'S FOUNDATION

By: Brandon Nefziger

INSIGHTEC LTD, an Israeli private company partially owned by General Electric, received the FDA's blessing to conduct a phase 1 trial for the treatment of Parkinson's disease that uses MRI scans to direct ultrasound energy bursts.

The non-invasive treatment is one of several uses of the device that is currently being tested for a family of devices - EXABLATE - which operates on the principle of ultrasound bursts directed and focused by MRI, including against cancer and against cancer metastases to the bones.

The device called EXABLATE NEURO uses focused ultrasound, pulses of ultrasound energy that can heat tissue in the body and destroy it. Using an MRI scan, doctors can direct the ultrasound waves, or sonication, while obtaining an image of the brain tissue in real time, while controlling the progress of the treatment.

According to Il Zadikario, vice president of research and development and director of the neuro program at the Carmelite company, the system is tested for activity deep in the brain, in the thalamus, to relieve tremors, a typical symptom of neurodegenerative diseases of the central nervous system. This area is also the target area for electrode implantation surgery in Parkinson's patients. These are connected to a pacemaker that sends currents to the brain and relieves the symptoms of the disease. Zadikario says the trial is expected to begin in the fall of this year. In the experiment, up to 30 patients with parkinsonian tremor as a dominant symptom will be recruited and will be divided into two groups, one will be treated with EXABLATE and the other will be a control group. Patients from this group will be able to also receive the treatment when the trial is over, says Zadikario. The main trial site at the University of Virginia in Charlotteville, where a trial was conducted last year with EXABLATE NEURO in the treatment of 15 patients with ESSENTIAL TREMOR, a medical condition, the treatment of which includes the destruction of a nearby area of ​​the brain, says Zdikario. "The clinical contribution of the disease is different, but the technique of the surgical procedure is similar," he tells DOTMED NEWS in a phone call. After the treatment for the ESSENTIAL TREMOR patients, they reported a "significant relief" in tremor and more than half of them reported a "dominant relief". There were minor side effects such as numbness in the fingertips and lips, but Zadikario says these are known to be due to brain damage in the area being tested and most of them went away after a week.

Big market

Because this treatment is non-invasive and does not require surgical implantation of the device and operates on batteries, which occasionally need to be replaced, Global Data, a British market research company, predicts that EXABLATE or a similar technology, if approved by the FDA, will take a huge share of the neurostimulation market, which was estimated in 2010 at $1.8 billion. . "The system has many advantages in that it is non-invasive, the therapeutic effect is immediate and is not accompanied by ionizing radiation," Global Data published last week.

Parkinson's disease affects one million Americans and 5 million worldwide, Global Data reported, and ranks 14th on the list of causes of death in the US.

EXABLATE other uses

Zadicario says that Virginia is the main site for the EXABLATE NEURO test in the US. The other two sites are Brigham Women's Hospital in Boston and the University of San Diego. The EXABLATE NEURO device is a relative of the EXABLATE. which received FDA approval in 2004 in UTERINE FIBROID. About 30 EXABLATE devices have been installed in the US, says Zadikario.

Insightek says it is investigating additional applications for EXABLATE. One application is to use the device to relieve pain in bone cancer metastases. These are now treated with painkillers or radiation. The company submitted an application to the FDA months ago for premarket approval, based on a trial in which the device was used to relieve pain in patients in whom radiation did not help as much, according to a press release earlier this year. The use for this purpose has been approved in Europe, says Zadikario.

Many other experiments using EXABLATE to test its activity in breast cancer and prostate cancer are in the stages of recruiting patients according to a search in a government database

clinicaltrials.gov

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Originally published on DOT ME NEWS