NeuroSigma to begin PhIII epilepsy device trial

NeuroSigma will begin a Phase III pivotal trial of its Monarch system for the treatment of drug-resistant epilepsy, having received IDE approval from the FDA. The external Trigeminal Nerve Stimulation (eTNS) system consists of an external electric pulse generator and a patch attached to a patient's forehead overnight to stimulate the large cranial nerve through the skin. In Phase I and II trials, over 40% of patients treated with the device showed a 50% or greater reduction in seizures, according to the L.A.-based company. Release