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Carlos Pe, Director, Department of Neurology and Physical Medical Devices, FDA's Device and Radiation Protection Center a, Ph.D., MS said: "Patients with idiopathic tremors that have not improved with drugs now have a new treatment option that may help them avoid invasive surgical treatment." "As with other treatments for essential tremors, This new device is not a cure but may help patients enjoy a better quality of life."
Idiopathic tremor, also known as benign essential tremor, is the most common form of tremor. According to the National Institute of Neurological Disorders and Stroke, millions of Americans, usually those over the age of 40, are affected by this condition. Essential tremors may be treated with beta blockers or anticonvulsants. If the drug control symptoms fail, this condition may also be surgically treated (thalamotomy of the thalamotomy) or a deep brain stimulation device that destroys the brain to control a small part of the involuntary movement (thalulus thalamus).
To determine if ExAblate Neuro treatment is appropriate, patients should first have nuclear magnetic MR and computed tomography (CT). Those who are undergoing MRI-guided devices are lying in a nuclear magnetic image scanner, and the images are taken to help the doctor in the target area of ​​the patient's thalamus. Gradually increase transcranial focused ultrasound energy treatment until the patient achieves tremor reduction. The patient is fresh and reactive throughout the treatment.
The safety and effectiveness of the data support device system included a double-blind controlled trial involving 76 patients with idiopathic tremor who did not respond to medication. Fifty-six patients were randomized to receive ExAblate Neuro treatment and 20 to receive false treatment. In the control group, the patient was able to be crossed to the treatment group after three months.
Patients treated with ExAblate Neuro compared to their baseline scores three months after treatment, and their tremor and motor function showed nearly 50% improvement (compression of tremor/motor function score). There was no improvement in the control group, and some experienced a slight deterioration after the false operation before they crossed to the treatment group. At 12 months after the operation, the treatment group retained a 40% improvement in these scores compared to baseline.
Adverse events to ExAblate Neuro were consistent with surgical reports of thalamic resection, including numbness/tingling of the fingers, headache, imbalance/unstable, loss of control of movement of the body (ataxia) or gait instability. Other side effects identified as possible may be associated with MR-guided focused sonication, including tissue damage in the treatment area, urgent treatment in the treatment area, skin burns with skin ulcers, skin contraction and scar formation, and blood clotting.
Patients with nuclear magnetic MR imaging cannot be contraindicated with ExAblate Neuro treatment, including those with implanted metal devices that are not compatible with MRI, such as cardiac pacemakers, patients with MR contrast agents, or patients with MR body size limitations.
Pregnant women, patients with end stage renal disease or dialysis, unstable heart conditions or severe hypertension, patients with behavior consistent with alcohol or substance abuse, or abnormal bleeding history, bleeding and / or blood clotting disease (coagulopathy) patients Treatment should not be used. Current administration of anticoagulants or drugs known to increase the risk of bleeding, patients with a history of cardiovascular disease (stroke) or brain tumors, and inability to withstand long periods of rest during treatment should not have this procedure.
ExAblate Neuro is manufactured by InSightec Corporation of Dallas, Texas.
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