NeuroSigma has announced top-line summaries of presentations made at the 11th European Congress on Epileptology in Stockholm, Sweden, related to the use of external trigeminal nerve stimulation (eTNS) in epilepsy.
Sean Slaght reported an update of observational findings in on-going adjunctive treatment with eTNS of adults at Kings College London, UK. In a group of 13 real-world, care-seeking patients with drug resistant epilepsy, who completed at least 12 weeks of nightly use of the Monarch eTNS system, they observed a median reduction in seizure frequency of 38%. The Kings College London researchers additionally reported on significant improvement in quality of life, mood, and sleep metrics.
In the first-ever use of eTNS in paediatric patients with drug resistant epilepsy, Slaght reported preliminary findings on seven children, age 10 to 17, treated with this non-invasive, adjunctive therapy. Three children (43% of the group) reported a 50% or more reduction of their seizure frequency after 18 weeks.
Observational findings were also presented by José Serratosa, from the Fundación Jiménez Díaz University Hospital, Madrid, Spain. In a group of eight adult patients treated with eTNS, 25% experienced a decrease in seizures of over 90%.
Consistent with earlier phase I and II trials conducted in the United States, the European groups reported an absence of serious adverse events.
Other investigators from Kings College London reported data on measures of cortical excitability in five adult drug resistant epilepsy patients undergoing eTNS treatment for 18 weeks. Brief magnetic pulses were used to assess cortical function before and after a course of treatment, in an effort to evaluate the mechanism of action of eTNS. Adam Pawley presented work conducted with Mark Richardson at Kings College London. Measures of cortical excitability consistently decreased with use of eTNS, implicating potential effects on signalling in both GABAA– and GABAB-mediated circuits. Other antiepileptic therapies have previously been shown to reduce measures of cortical excitability.
Christianne Heck from the University of Southern California (USC), Los Angeles, chaired a satellite symposium, “Trigeminal Nerve Stimulation (TNS): Neuromodulation for the 21st Century.” This session introduced TNS to a large number of epileptologists attending the Congress and provided them with both background neurobiological data and clinical results.
“The experience at these leading European epilepsy centres bears out the safety profile we have seen in the USA for eTNS, and provides confirmatory evidence of the effects of eTNS on seizures, mood, sleep, and quality of life,” says Christopher DeGiorgio, NeuroSigma’s vice president of Neurology and the professor of Neurology who first investigated eTNS for drug resistant epilepsy at the University of California, Los Angeles (UCLA). “Millions of people living with epilepsy are still having seizures despite the best medication treatment available, often facing cognitive side effects from multiple antiepileptic drugs and the disease itself. eTNS may become an important tool to address this unmet medical need.”
“While these studies were of modest size, the researchers conducting these independent effectiveness evaluations are in the vanguard in providing important data that complement the findings from controlled clinical trials. These findings provide us with confidence in the design of the pivotal trial in drug resistant epilepsy that we are preparing to commence. Further, the work with cortical excitability elucidates another biological mechanism by which eTNS may achieve its anticonvulsant effect, and builds on the data showing acute changes in regional brain activity observed with PET scanning at UCLA,” adds Ian Cook, chief medical officer and senior vice president at NeuroSigma.
NeuroSigma provided eTNS Systems to the investigators’ institutions, but was otherwise uninvolved in the conduct of the research at either Kings College London or the Fundación Jiménez Díaz University Hospital.