Neurostimulation device reduces seizure frequency in adults with drug-refractory epilepsy

Key takeaways:

• Focal cortex stimulation with an implantable device reduced seizure activity in more than 50% of participants at 6 months.
• No significant changes in mood or quality of life were reported by participants.

In adults with drug-refractory focal epilepsy, treatment with an implanted neurostimulation device was safe and associated with significant reduction in seizure frequency, according to a study published in JAMA Neurology.

“Despite the availability of new antiseizure medications, more than one-third of patients with epilepsy do not sufficiently respond to drug therapy, particularly those with focal epilepsy” Andreas Schulze-Bonhage, MD, of the Epilepsy Center at the University of Freiburg in Germany, and colleagues wrote.

Researchers conducted a pooled analysis of results from two prospective, nonrandomized, multicenter, uncontrolled single-arm trials, EASEE II and PIMIDES I, which assessed the safety and efficacy of epicranial focal cortex stimulation (FCS) with the implantable EASEE system (Precisis) as adjunctive treatment for adults with drug-refractory focal epilepsy. The trials began in 2019 and 2020, respectively, and ended in 2021.

Thirty-four participants were recruited at seven European epilepsy centers, of whom 33 (mean age, 34.6 years; 54.5% men) received the neurostimulation implant. Thirty-two individuals underwent combined high-frequency direct current stimulation after a 1-month post-implantation recovery period, which continued through an 8-month follow-up.

Participants recorded seizure activity and completed symptom-related questionnaires, with researchers collecting data at visits through 8 months.

After 6 months of stimulation, results showed 53.1% of participants (n = 17) responded to treatment with a reduction in seizure frequency of at least 50% compared with baseline, which corresponded to a median seizure reduction by 52% (95% CI, 0.37-0.76). Researchers reported no serious adverse events involving the device or the procedure, and there were no significant changes in cognition, mood or overall quality of life.

“The safety profile of implantable epicranial stimulation was favorable compared with published safety profiles of alternative neuromodulation or surgical procedures and compared with the risks associated with uncontrolled seizures,” Schulze-Bonhage and colleagues wrote.