Non-invasive TI Stimulation for Temporal Lobe Epilepsy

(TI-HPC-TLE Trial)

This trial explores whether a new, non-invasive treatment called Temporal Interference (TI) Stimulation can reduce seizures and improve sleep in people with drug-resistant temporal lobe epilepsy. The treatment applies gentle electrical stimulation to the brain during sleep. Participants will spend several nights in a lab to determine if this approach lowers seizure activity and enhances sleep quality. This trial may suit those with long-standing temporal lobe epilepsy who haven't found relief with medication. Participants must be comfortable staying overnight in a lab for monitoring. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new treatment options.

The trial does not specify if you need to stop your current medications, but it requires that your antiseizure medication regimen is stable for at least one week before joining. It's best to discuss your specific situation with the trial team.

Research has shown that non-invasive temporal interference (TI) stimulation is generally safe for people. One study on TI stimulation's safety found it well-tolerated, with no serious side effects reported. Participants did not experience major problems with brain function or thinking abilities.

Another safety review of TI stimulation found that mild side effects, such as slight skin irritation, can occur, but these are usually minor and temporary. This method uses electrical currents to target specific brain areas without surgery, making it safer than more invasive treatments.

Unlike the standard treatments for temporal lobe epilepsy, which often involve medications like antiepileptic drugs or invasive procedures like surgery, non-invasive Temporal Interference (TI) Stimulation offers a unique, non-invasive approach. This method uses targeted electrical stimulation to influence brain activity, specifically focusing on the bilateral hippocampi, without the need for surgery or implants. Researchers are excited about TI Stimulation because it has the potential to reduce seizures while minimizing side effects and risks associated with more invasive techniques. Additionally, this approach might offer a new way to monitor and improve cognitive and mood outcomes in patients with epilepsy.

Research has shown that non-invasive temporal interference (TI) stimulation can target the hippocampus, a brain region that helps control seizures. Studies have found that similar deep brain stimulation methods can reduce seizure frequency by affecting brain areas involved in seizures. Specifically, TI stimulation has lowered signals indicating seizure activity, known as epileptic biomarkers. This approach has proven effective in both animal studies and early human tests. In this trial, participants will undergo TI stimulation during overnight sessions. Initial results suggest that TI stimulation might help reduce seizures and improve sleep quality in people with temporal lobe epilepsy.¹²³⁵⁶