ExAblate Neuro works by using magnetic resonance imaging (MRI) to help doctors target the precise brain location causing the tremors. With this information, doctors send ultrasound waves, which ablate that small portion of brain tissues. The idea is to kill the brain tissues responsible for the tremors with as little damage to other brain areas as possible.
Neurological diseases, such as Parkinson’s and essential tremor, are characterized by involuntary and rhythmic shaking. Most notably, the disease affects muscle movements in the hands, causing trembling and tremors as patients perform ordinary tasks like picking up a cup or writing. Some medications, like beta-blockers, anticonvulsants, and even a Botox-like drug, can be effective to manage the tremors. However, not everyone responds to medications. More invasive options to treat essential tremors include deep brain stimulation, or the removal of the thalamus, a region of the brain that controls voluntary movements.
"Patients with essential tremor who have not seen improvement with medication now have a new treatment option that could help them to avoid more invasive surgical treatments," said Carlos Peña, director of the division of neurological and physical medicine devices at the FDA's Center for Devices and Radiological Health.
With ExAblate Neuro, specific spots in the thalamus are targeted for ablation. The patient lies in an MRI scanner that create a targeted map for the doctors. Then, ultrasound energy is focused to that spot until patients notice improvements in their tremors. Because the patient is awake during this procedure, doctors are able to get valuable, real-time feedback on the treatment.
The FDA approval came after the device demonstrated superior results in clinical trials. In 56 patients who were randomized to receive the ExAblate Neuro treatment, nearly 50 percent showed a significant improvement in their tremors. By contrast, the 20 patients in the control group did not show improvement, and some even had a worsening of their symptoms. The improvements in tremors seem to be long lasting, as patients who received the treatments still reported positive changes at the one-year mark.
It is important to note, though, that the new treatment is a new way to manage symptoms of essential tremors. And, even though the treatment is considered less invasive, killing brain tissues is not without side-effects. These include imbalance, gait changes, ataxia, and numbness in the limbs. But for the millions of Americans who suffer from the tremors, this new procedure could make a difference in their symptoms, for the better. "As with other treatments for essential tremor, this new device is not a cure but could help patients enjoy a better quality of life,” said Peña.