World's First Focused Ultrasound Clinical Trial for Epilepsy Begins
Researchers at the University of Virginia (UVA) are starting the first clinical trial in the world using focused ultrasound to treat patients with epilepsy. The study, supported by the Focused Ultrasound Foundation in collaboration with the Epilepsy Foundation, will assess the feasibility, safety and initial effectiveness of focused ultrasound to non-invasively destroy (ablate) diseased brain tissue that causes seizures.
The study is now recruiting up to 15 adult patients with a range of rare deep brain lesions that produce debilitating seizures that often do not respond to medications. It is expected that most patients in the study will have benign tumors in the hypothalamus, which can lead to frequent seizures with outbursts of spontaneous laughing, giggling, crying or grunting; developmental delays and/or precocious puberty. The disorder can progress as patients age, leading to increased cognitive decline and severe behavior problems.
Current options for patients whose seizures do not respond to medication include surgery or laser thermal ablation, both which may involve multiple risks or complications, such as damage to normal brain, infection or hemorrhage. The only currently available non-invasive method is radiosurgery with the gamma knife, which may take months to show effect, is not image guided and involves risks of complications from radiation.
“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,” says principal investigator Nathan Fountain, MD, professor of neurology at UVA. “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.”
Dr. Fountain will collaborate with UVA neurosurgeon Jeff Elias, MD, in conducting the procedures using Insightec’s Exablate Neuro System. Patients seeking further information about the study should contact Stacy Thompson, RN at SRC2H@virginia.edu or Nathan Fountain, MD at NBF2P@virginia.edu.
Momentum Building for FUS and Epilepsy
“We are committed to advancing the technical, scientific and clinical work required for focused ultrasound to reach its full potential in treating epilepsy,” said Foundation Chairman Neal Kassell, MD. “This is the first in a planned series of studies in epilepsy that the Foundation is supporting.”
In addition to the UVA study, the Foundation plans to support a clinical trial led by Neurosurgeon Vibhor Krishna, MD, at Ohio State University using focused ultrasound to ablate the anterior nucleus of the thalamus in patients with partial-onset epilepsy.
Neurosurgeon Tomokatsu Hori at Tokyo Women’s Medical University recently applied focused ultrasound to a patient with temporal lobe epilepsy (TLE) to assess feasibility of reaching this target. This is the first step that may ultimately lead to a clinical trial to treat TLE.
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