Treatment FAQs

1. What results can I expect from this treatment?
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Based on clinical studies*, the procedure presents favorable results.  Studies show significant reductions in tremor, resulting in improvement of activities such as: eating, drinking, writing, hygiene, dressing, working and social activities.

2. What clinical data backs the Neuravive procedure?
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There have been several papers published on the results of this procedure including a randomized, placebo controlled clinical trial that was published in a leading medical journal. This study provides the highest level of evidence as deemed by physicians to validate the safety and effectiveness of the procedure.

3. How accurate is the technology?
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MR guided focused ultrasound neurosurgery is as accurate as any other interventional treatment option – generally accurate to 1mm or less.

4. What information should be shared with your doctor?
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– If you ever experienced allergic reactions to imaging contrast media.

– If you have any medication allergies.

– If you take any medications on a regular basis.

– If you have a tendency for blood clots (due to the period of immobilization required by the treatment).

It is extremely important to discuss all these conditions with your physician so your suitability for the procedure can be properly evaluated.

5. Are there any other requirements to be considered for this procedure?
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Besides having a confirmed diagnosis of Essential Tremor, your doctors will want to be sure that you have tried at least one medication for Essential Tremor and have found that it does not help you or has undesirable side effects.

6. Is there a physical height or weight limitation that accompanies this procedure?
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Since the procedure is done in the bore of the MRI scanner there is a physical weight limit which is generally in the range of 300 lbs.

7. What complications could happen while undergoing this procedure?
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Your doctor is the best person to ask about this. He or she will be able to tell you if you are a suitable candidate for the Neuravive treatment. In general, people who cannot go into an MRI will not be able to go through the treatment. This includes patients with metallic implants, patients who are claustrophobic, and patients who are allergic to contrast agents – a dye used to see blood vessels during MR imaging.

Overall, Neuravive is a safe procedure for treating Essential Tremor. Infrequent complications that have been reported following MRgFUS are listed below. You should talk to your doctor about the likelihood of experiencing any of these risks:

– You may experience pain and/or bruising at the sites where the immobilizing frame is attached tightly to your head. This could occur for hours or days after the procedure.

– You may experience bruising in the area of the IV catheter following the procedure similar to that experienced after blood draws. Any bruising should resolve on its own within a week.

– Nausea/Vomiting were also reported in some instances. It is unclear if this is related to medications used during the treatment or the procedure itself.

Any questions concerning risks and/or complications of the procedure, should be discussed with your doctor.

8. What are the pros and cons of this procedure over the other treatment options?
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Pros:

Completely noninvasive (no incision or no penetrations of the brain with probes)

No anesthesia

No hospitalization

Speedy recovery and return to normal life

Outstanding safety profile

No ionizing radiation

Does not involve implanted electrodes or pacemakers that require follow up, replacement, and can cause infections.

Cons:

Because it is not adjustable like stimulation, it will not be able to be adjusted after initial treatment

It does not have as long a history of long-term outcomes like deep brain stimulation.

9. After the procedure, what will happen?
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The Neuravive treatment is intended for Essential Tremor patients who have not responded to medication. It is important to consult with your physician, to determine if the Neuravive treatment is right for you.

As part of the evaluation process, your physician will need to determine the severity of your tremor and perform a full medical evaluation to assess your overall condition.  This is necessary to ensure a safe and effective Neuravive treatment for your condition.

Patients will also need to undergo a CT scan in order to verify that Neuravive is suitable for them.

Those undergoing treatment with Neuravive lie in an MRI that takes images to help a doctor identify the targeted area in the brain for treatment.  If you have metallic implants such as pacemakers, neuro-stimulators, spine or bone fixation devices, total joints, metal clips, screws, etc. you will need to consult with your doctor to see if Neuravive is an option for you. Any metallic implants must be non-magnetic to prevent injury to the patient from the MRI’s strong magnetic field.

10. Who will provide my post procedure care following the treatment?
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It is important that you discuss with your doctor ahead of time who will handle your follow-up care. Be sure to arrange follow-up phone calls and/or office visits for after the procedure. The patient should also know who to contact in case of an emergency after procedure.