FDA Grants Breakthrough Device Designation for Transcranial Neurostimulation for Drug-Resistant Epilepsy

The Food and Drug Administration (FDA) granted breakthrough device designation for a transcranial neurostimulation (TNS) device for Drug-Resistant Epilepsy (DRE) (Monarch eTNS System; NeuroSigma, Los Angeles, CA). This TNS device is for adjunctive use for reducing the frequency of seizures in individuals age 18 years or more. 

Individuals who are diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization that are refractory to 2 or more antiepileptic medications. In the journal Brain Stimulation, study results show 40 individuals with DRE were randomized to receive either TNS or their usual medical treatment. Participants were followed for 1 year and evaluated for changes in seizure frequency, side effects and quality of life. 

At the 6 and 12-month timepoints, there was a 50% responder rate in individuals receiving eTNS versus a 0% responder rate among individuals randomized to the control group (P<.001). After 12 months there was a median reduction in seizure frequency of 43.5% in the eTNS group versus 0% in the control group (P=.0013). 

“We are delighted to achieve Breakthrough Device Designation for the Monarch eTNS System. Clinical trials of the device in patients with DRE have shown impressive results comparable to those achieved with adjunctive pharmaceutical and implantable device therapies,” commented Dr. Colin Kealey, president of NeuroSigma. “This Breakthrough Device Designation will expedite completion of a pivotal trial of external trigeminal nerve stimulation (eTNS) therapy for DRE. We are confident the Monarch eTNS System can become an important therapeutic option for the millions of patients worldwide who continue to suffer from seizures despite medication therapy.”

“With an FDA clearance for pediatric ADHD and now Breakthrough Device Designation for DRE, NeuroSigma continues to demonstrate the Monarch eTNS System is a safe and effective alternative to drug-based or surgical treatments for an expanding number of serious diseases,” commented Tom Paschall, director of NeuroSigma. “As a noninvasive, wearable therapy, the Monarch eTNS System is an exciting alternative to drugs, implantable devices, and brain surgery and avoids many of their negative side effects.”

There were no significant adverse events associated with use of eTNS, and the treatment was well tolerated for the duration of the trial.