DBS Parameter Optimization for Epilepsy

This trial aims to fine-tune deep brain stimulation (DBS) settings for people with epilepsy who don't respond to medication and can't undergo surgery. The goal is to use implantable neural stimulators (INSs) to reduce seizures and ideally stop them altogether. Participants will receive different stimulation settings to find the best fit for their needs. This trial suits those with hard-to-treat epilepsy who already have a DBS device implanted. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to benefit from these advancements.

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Research has shown that deep brain stimulation (DBS) is generally safe for treating epilepsy. In a study with 110 patients, researchers used DBS safely over many years. The FDA has approved it to help reduce seizures in people with difficult-to-treat epilepsy. The treatment is usually well-tolerated, but like any medical procedure, it carries some risks. Most reports highlight that DBS lowers the number of seizures, with an average reduction of 62%. While side effects can occur, they are usually manageable. Overall, DBS has a strong safety record when used for epilepsy.¹²³⁴⁵

Researchers are excited about this trial because it explores how to optimize Deep Brain Stimulation (DBS) for epilepsy using different stimulation settings. Unlike traditional epilepsy treatments like anti-seizure medications or resective surgery, this trial focuses on fine-tuning the parameters of already implanted neural stimulators to enhance their effectiveness. By varying the order and type of electrical stimulation, the trial aims to discover the most effective patterns for reducing seizures, potentially offering a more personalized and precise approach to managing epilepsy.

Research shows that deep brain stimulation (DBS) effectively reduces seizures in people whose epilepsy doesn't respond to medication. Studies have found that DBS decreases seizure frequency and duration, with improvements increasing over time. Another review noted that many patients experienced fewer seizures. The well-known SANTE trial reported a 40.4% reduction in seizures with DBS. The FDA has approved DBS for epilepsy, supporting its effectiveness for difficult-to-treat cases. In this trial, participants with already implanted DBS devices will join different stimulation groups to optimize parameters for seizure reduction.¹²⁴⁵⁶