First Clinical Trial to Treat Epilepsy Using Focused Ultrasound Is Underway

First Clinical Trial to Treat Epilepsy Using Focused Ultrasound Is Underway

Researchers at the University of Virginia (UVA) started the first clinical trial to test focused ultrasound as a therapy for patients with epilepsy.

The Focused Ultrasound Foundation and the Epilepsy Foundation are supporting this study, the first stage of which aims to determine the viability, safety, and initial effectiveness of focused ultrasound to destroy the damaged brain tissue that causes the symptoms of epilepsy.

Focused ultrasound is a noninvasive therapeutic technology that makes use of ultrasonic energy to target deep tissues in the body. Overall, this technology has the ability to stop seizures without resorting to incisions or radiation. Focused ultrasound can be extremely precise and accurate with few side effects or complications and minimal discomfort for the patient.

The study, “MR-Guided Focused Ultrasound in the Treatment of Subcortical Lesional Epilepsy (EP001),” (NCT02804230) is now recruiting 15 adult patients presenting seizure occurrence due to rare deep brain lesions.

The researchers expect that most patients will have benign tumors in the hypothalamus region, nonresponsive to medication. These situations frequently lead to seizures with outbursts of spontaneous laughing, giggling, crying, or grunting. Indeed, this disorder can ultimately lead to cognitive deterioration and severe behavior problems.

In these situations, where medication is not efficient to reduce seizures, the clinical approach options are surgery or laser thermal ablation. These therapeutic methods allow blocking brain damages from spreading, but imply multiple risks or complications, such as brain damage, infection, or hemorrhage.

Gamma knife radiosurgery is the only noninvasive method that is currently used. Still, clinical effects from this technique are very slow, often taking months for patients to show improvements. And complications due to the side effects of radiation are also a problem.

“Intractable epilepsy, especially this type, can be devastating, and existing therapies have risks and are not uniformly effective, so many patients are in desperate need of better therapies,” Dr. Nathan Fountain, MD, principal investigator of the study and a professor of neurology at UVA, said in a news release.

“If we are successful in destroying the lesions without complications, then this will be an important step on the path toward developing focused ultrasound to enable patients to have freedom from seizures without the risks of open surgery,” Fountain said


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