What is the Focused Ultrasound treatment?

Focused Ultrasound is a treatment for essential tremor where sound waves are focused through the skull to a target without the need for incisions, brain implants or radiation. It is based on high intensity focused ultrasound guided by MR imaging.

During the procedure, ultrasound waves pass through the skull and are focused on a specific target in the brain. The temperature at the target rises high enough to create a small ablation, or burn and provide a therapeutic effect, reducing the hand tremor.

The MRI scanner provides images for the physician to clearly see the treatment area and to show changes in temperature at the target.

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Before the treatment

On treatment day, your head will be shaved so that nothing will interfere with the ultrasound beams. Your hair will naturally grow back after the treatment. After local numbing medication is applied, a frame will be secured to your head and an elastic cap is placed to seal the helmet, where water is circulated.

Your heart rate, blood pressure and blood oxygen levels will be monitored throughout the procedure.

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During & after the treatment

During the treatment, you will lie down on the treatment bed inside the MRI scanner. The medical team will be in the control room and you will be conscious and able to communicate with them. Your head will be positioned in the focused ultrasound helmet which is filled with water, and you will have a blanket to keep you warm.

You will be given a “stop sonication” button if for any reason you want to stop the procedure. MR images are taken to plan the treatment.

Your physician will first apply light doses of ultrasound energy to identify the right spot in your brain for treatment. Then full intensity ultrasound energy will be applied. The temperature at the target rises high enough to create a small ablation, or burn and provide a therapeutic effect, reducing the hand tremor. The treatment bed will move in and out of the MRI.

After each application of ultrasound energy, you will be asked to do tasks such as drawing spirals. This is so the physician can evaluate the improvement of your tremor and any potential side effects.
Although individual results may vary, you should notice improvement during the treatment itself. At the end of the procedure a final MRI scan will be done to assess the treatment. The frame will be removed and you will go to a recovery room.

Your physician will let you know when you can go home and when you will need to return for any follow-up visit.

Within days you can return to normal activities.

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Risks & side effects

Important Safety Information

You should have a detailed conversation with your physician regarding the risks and benefits of treatment options prior to treatment.

The most common complications reported by subjects in Insightec-sponsored clinical studies after treatment included: imbalance/gait disturbance (26% of study patients), numbness/tingling (33%), and headache/head pain (51%).

Most complications were classified as mild or moderate, and 48% resolved on their own within 30 days. Additional infrequent events include dizziness, taste disturbance, slurred speech, fatigue and vomiting.

Persistent complications at three-years included: numbness/tingling (9% of study patients), imbalance (4%), unsteadiness (4%), gait disturbance (2%), and musculoskeletal weakness (2%).

For complete safety information, please visit: https://essential-tremor.com/safety-information-and-ce-labeling/

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*FDA Labeling: The Exablate Neuro is intended for use in the unilateral thalamotomy of idiopathic essential tremor patients with medication-refractory tremor. Patients must be at least age 22.

**Disclaimer: The information provided here should not be considered medical advice and is not intended to replace consultation with a qualified physician. Please consult with your physician or clinic for diagnosis and treatment.