Approval Received for Essential Tremor Study


In early February, global healthcare company Insightec shared that the company received FDA approval for its new study. Within the study, Insightec will evaluate Focused Ultrasound as a potential therapy for patients with essential tremor that does not respond to treatment. The Focused Ultrasound treatment was developed using Insightec’s proprietary Exablate Neuro platform, which was approved in 2016.

Exablate Neuro

The company describes the platform as:

an innovative neurosurgery platform that can deliver ultrasound energy deep in the brain to create a lesion with no incisions. During a focused ultrasound treatment, the neurosurgeon sits at a computer console in the MRI control room, using a computer workstation and mouse instead of scalpel.

So how does the Exablate Neuro platform work? Insightec explains that:

Exablate Neuro features advanced hardware that can produce ultrasound powerful enough to penetrate the skull, software that takes into account individual skull shape and thickness, and a sealed water system that actively cools the skull during the treatment. Up to 1024 ultrasound waves precisely heat and ablate a deep brain target with no surgical incisions.

Essential Tremor Study

During the study, researchers will evaluate the safety and efficacy of using Focused Ultrasound to treat both sides of the body. So far, 15 patients have enrolled. All patients must be at least 22 years old and have essential tremor that has not responded to medication. Additionally, patients in the trial attempted unilateral treatment (affecting one side of the body) around 9+ months prior to enrolling.

If this bilateral treatment is effective, it could offer a new and more effective way to treat patients. Additionally, this would improve quality of life (QOL) and help patients live a more independent life.

Essential Tremor

Essential tremor is a nervous system disorder characterized by involuntary or rhythmic shaking. Although the tremor can appear anywhere in the body, it often affects the hands. While essential tremor is progressive, and may get worse over time, it is typically not dangerous or harmful. Essential tremor is genetically caused in around 50% of cases and idiopathic (with no known cause) in the other 50%. Typically, this condition impacts those over 40. Movement, stress, fatigue, temperature changes, and caffeine can all exacerbate symptoms. These symptoms include:

  • Tremors
  • Shaking or nodding the head
  • Involuntary movements
  • Difficulty eating, talking, writing, shaving, or performing other small movements

Learn more about essential tremor here.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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