Trigeminal Nerve Stimulation for Epilepsy

This trial explores a new method to assist veterans with epilepsy who continue to experience seizures despite taking seizure medications. Researchers are testing whether a device called Cefaly, initially designed for migraines, can reduce seizures by stimulating a nerve in the forehead without surgery. Participants will either receive this treatment or continue with standard care, then switch groups to compare results over a year. Ideal candidates are veterans with focal epilepsy, experiencing at least one seizure every four weeks, and who have not benefited from at least two different seizure medications. As an unphased trial, this study offers veterans the chance to explore an innovative treatment option that could potentially enhance their quality of life.

The trial does not require you to stop taking your current medications. In fact, participants must be on at least one antiseizure medication with stable doses for at least three months before joining the study.

Research has shown that the Cefaly device, which stimulates a nerve in the face, is generally well-tolerated by people with medication-resistant epilepsy. In earlier studies, patients reported only minor side effects, such as mild anxiety, headaches, and some skin irritation. Importantly, these effects were not severe enough to cause most people to stop using the device.

Trigeminal nerve stimulation is unique because it offers a non-drug approach to managing epilepsy. Unlike standard treatments that often rely on medications to control seizures, this technique uses mild electrical impulses to stimulate the trigeminal nerve, which may help stabilize brain activity. Researchers are excited about this treatment because it could provide a new option for patients who experience side effects from traditional anti-seizure drugs or for those who haven't found success with existing medications. Additionally, its non-invasive nature means it could be easier to use and potentially have fewer side effects.

Research has shown that stimulating the trigeminal nerve (TNS) might be a promising way to treat epilepsy. In an initial study, over half of the participants experienced a 50% or more reduction in seizure frequency after using TNS for three months. Other studies have found that TNS is generally well-tolerated and may also improve mental health while reducing seizures. In this trial, participants in the experimental arm will receive treatment with the Cefaly device, which uses this non-invasive method. Although originally designed for migraines, early results suggest it might also help people with medication-resistant epilepsy by reducing seizure rates.¹³⁴⁶⁷