Early-phase abstract reports closed-loop subgaleal stimulation safety and seizure reduction in epilepsy patientsShort-pulse brain stimulation cut seizures by up to 83% in early epilepsy trials

medRxiv Published April 21, 2026 Study authors: Chadaide, Z.; Fabo, D.; Szoboszlay, M.; Barcsai, L.; Pejin, A.; Horvath, B.; Gorog, M.; Foldi, T.; A… DOI ↗ Editorial oversight: Dr. Ji-eun Park, MD · Brain, Mind & Pain

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Key Takeaway

Consider closed-loop subgaleal stimulation as a candidate therapy for drug-resistant epilepsy based on preliminary safety and efficacy data.

This first-in-patient study abstract evaluates closed-loop, subgaleal intersectional short-pulse (ISP) stimulation delivered transcranially through subgaleally implanted electrodes in patients with epilepsy. The setting was inpatient treatment with a follow-up duration of the first three days of inpatient treatment. The primary outcomes assessed were safety, feasibility, and effectiveness. Absolute numbers were not reported for the outcomes, and p-values or confidence intervals were not reported.

Key results indicated that seizure duration was reduced by 53% and seizure incidence was reduced by 83%. Tolerability was described as promising, while adverse events, serious adverse events, and discontinuations were not reported. The study was an early-phase trial with preliminary evidence status.

Limitations acknowledged by the authors include the preliminary nature of the evidence. Funding or conflicts were not reported. The practice relevance suggests ISP as a candidate therapy for drug-resistant epilepsy. Causality was not reported, and certainty is limited by the early-phase design. Do not overstate the findings given the preliminary evidence and first-in-patient study constraints.

For people with drug-resistant epilepsy, finding a new way to stop seizures is urgent. A small early-phase study looked at a closed-loop, subgaleal intersectional short-pulse stimulation system. This device delivers tiny electrical pulses through electrodes placed just under the scalp. The goal was to see if it was safe and could work quickly.

During the first three days of inpatient treatment, the results were striking. Seizure duration dropped by 53%, and the number of seizures fell by 83%. The team found no serious side effects or reasons to stop the treatment early. Safety looked promising for this specific approach.

However, this is preliminary evidence from a first-in-patient study. We do not yet know how it works over months or years. More research is needed to confirm if these early gains last. Still, this supports the idea that this stimulation could be a candidate therapy for those who have not found relief from other treatments.

What this means for you:

Early data shows this brain stimulation reduced seizures by up to 83% with promising safety.

Study Details

EvidenceLevel 5

PublishedApr 2026

View Original Abstract ↓

Approximately one-third of epilepsy patients do not respond to antiseizure medications (ASM), are not suitable candidates for curative surgical interventions, or have unsuccessful surgical therapies. Currently, the available repertoire to treat this patient pool is limited. Only a few viable solutions have been approved by the US Food and Drug Administration (FDA): deep brain stimulation (DBS), vagus nerve stimulation (VNS), and responsive neurostimulation (RNS). However, these almost exclusively lack adaptability, the ability for continuous monitoring for extended periods, and closed-loop stimulation with high accuracy and spatiotemporal specificity while requiring invasive implantation strategies that pose several risk factors to the patients involved. We sought to improve these aspects as we developed a minimally invasive, adaptive neuromonitoring tool combined with automatic epileptic seizure detection and intersectional short-pulse (ISP) stimulation to immediately terminate pathological brain activity without the need to wait long periods (i.e., weeks to months) for the seizure-altering effect to build up. We conducted a first-in-patient study assessing the safety, feasibility, and effectiveness of ISP stimulation delivered transcranially through subgaleally implanted electrodes in patients with epilepsy. Our preliminary evidence shows that ictal ISP stimulation instantaneously reduced seizure duration by 53%, modulated spectral content, and effectively inhibited secondary generalization. Moreover, closed-loop ISP stimulation reduced seizure incidence by 83% within the first three days of inpatient treatment. The combination of a minimally invasive implantation strategy with precise, closed-loop ISP delivery demonstrated promising safety and acute efficacy and supports ISP as a candidate therapy for drug-resistant epilepsy. This trial is registered at ClinicalTrials.gov, identifier NCT07041619.

Early-phase abstract reports closed-loop subgaleal stimulation safety and seizure reduction in epilepsy patientsShort-pulse brain stimulation cut seizures by up to 83% in early epilepsy trials

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Early-phase abstract reports closed-loop subgaleal stimulation safety and seizure reduction in epilepsy patientsShort-pulse brain stimulation cut seizures by up to 83% in early epilepsy trials

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