FDA Allows Study of Bilateral Ultrasound Treatment of Essential Tremor 

The Food and Drug Administration (FDA) has given Investigational Device Exemption (IDE) approval for a pivotal study (NCT04112381) of a device (Exablate Neuro Focused Ultrasound; Insightec, Miami, FL) that provides staged bilaterally focused ultrasound treatment for essential tremor that is refractory to medical treatment. The FDA approved the device in 2016 for treating medication-refractory essential tremor unilaterally.  

The clinical trial, which has 15 participants to date, is evaluating the safety and efficacy of bilateral treatment in people age 22 or more who have a diagnosis of medication-refractory essential tremor and had unilateral focused ultrasound treatment at least 9 months earlier. 

“When essential tremor patients have significant tremor on both sides of their body, a staged, bilateral focused ultrasound procedure may offer clinical benefit,” said Howard Eisenberg, MD, the Raymond K. Thompson, MD, Chair in Neurosurgery; professor, department of neurosurgery, University of Maryland School of Medicine; and neurosurgeon, University of Maryland Medical Center. “This is an important study to evaluate a second focused ultrasound treatment performed at least 9 months after the first arm was treated.”