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Focused Ultrasound Clinical Trial Results

By: The INSIGHTEC Marketing Team
July 18, 2018

Thomas took great pride in playing darts. His father had schooled him well in this family tradition that went back decades. However, when his father reached his 60’s, he was diagnosed with essential tremor. At that point, his hand shook so much that he could no longer throw the darts with precision.

Knowing essential tremor can be hereditary, when Thomas began experiencing similar symptoms in his left hand, he went straight to a neurologist. Soon after he was informed he too had essential tremor.

Early on in treatment it became clear that medication was not working. His neurologist believed the problem could be solved, but he didn’t have a solid plan as to how. One day Thomas got a call from him that changed everything.

His neurologist explained that a new technology had been developed to treat essential tremor. It would soon be tested in clinical trials for FDA approval, and he could sign Thomas up to be a candidate. He explained the procedure was a type of neurosurgery that did not require an incision. Huh? Thomas was skeptical but interested to learn more about it.

So he did some research. The treatment was called Neuravive. The technology allowed neurosurgeons to focus ultrasound waves through a helmet-like device to meet a point deep in the brain called the thalamus—a brain structure involved with movement. The procedure was done inside an MR imaging scanner.  The MR images helped the neurosurgeon guide the path of the waves and monitor the procedure.

The ultrasound waves pass through the skull bringing energy to the very specific spot in the thalamus that is responsible for tremor. This energy creates an ablation, or tiny burn, smaller than a pea. The ablation would help to control Thomas’s tremor. He decided that if there was a possibility that the treatment could work, he would try it.

He learned that Neuravive was being studied in clinical trials across 8 international medical centers. The patients in the study had moderate-to-severe essential tremor and had taken at least two rounds of medication without improvement. Although there were many other participant requirements, Thomas fortunately met them all.

In the trials, the treatment was compared across two patient groups. He did not know which one he was in. One group received the Neuravive treatment. The second group did not receive treatment (referred to as the sham group) to measure the potential placebo effect. After 3 months, patients in the sham group were given the opportunity to receive the same focused ultrasound treatment as the treatment group.

The researchers looked at patients before and after treatment over a 1-year period. They measured the changes in the hand tremor, ability to perform everyday tasks, and level of disability. A questionnaire was also used that measured the impact of their hand tremors on quality-of-life. Finally, an independent group of neurologists performed tremor assessments by rating videotapes of patients.

The results were breath taking. Thomas’s treatment led to an improvement in the tremor on his treated hand immediately following the treatment, and he went home the same day. He was so happy he cried. But was he unique—were other essential tremor sufferers being treated safely and effectively too?

Reading the results of the clinical trial revealed that patients that had the focused ultrasound treatment showed an improvement of 47% in composite hand tremor and motor function at 3 months. At 12 months, patients maintained a 40% improvement, which was not statistically different from the 3-month score. Tremor (at rest, posture and activity) improved by 66% at 12 months. In addition, patient-reported quality-of-life scores also changed significantly, as shown by a 47% improvement of tremor-related challenges they faced.

Neuravive was considered to be safe too. In clinical trials, safety is measured by the number of adverse events. Adverse events are unfavorable and unintended symptoms, or medical occurrences, associated with the use of a medical product and related to the timing of treatment. The most common persistent adverse events related to this treatment were numbness/tingling (experienced by 12% of trial participants), imbalance (5% of participants), unsteadiness (2% of participants), and gait disturbance (problems with walking) (2% of participants).

Reading the results of the clinical trial revealed that focused ultrasound treatment showed an improvement of 47% in hand tremor at 3 months. At 12 months, patients maintained a 40% improvement, which was not statistically different from the 3-month score. In addition, patient-reported quality-of-life scores also improved significantly, as shown by a 43% reduction of tremor-related challenges they faced.

Learn More

Exablate Neuro is intended for use in the unilateral thalamotomy treatment of idiopathic Essential Tremor patients age 22 or older with medication-refractory tremor.

Click here for the FDA approval and labeling information.

Click here to download the patient brochure.

 

*Thomas is a fictitious character used to portray a patient.

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