NCT07041619

Subcutaneous Intersectional Short Pulse Stimulation in Epileptic Patients

Changes in Brain Activity as a Function of Scalp and Subcutaneous Electrical Stimulation Parameters in Epileptic Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A subgaleal electrode-based system combined with the novel intersectional short-pulse (ISP) stimulation was developed to enable non-invasive, high-intensity neuromodulation. ISP consists of ultra-brief, distributed pulses to maximize electric field strength in target areas while minimizing adverse effects on non-target tissues. Early preclinical studies demonstrate its efficacy in disrupting pathological oscillations and reducing seizures in animal models. This study investigates how targeted electrical brain stimulation by ISP stimulation impacts brain activity in epilepsy patients. The research aims to determine if ISP stimulation delivered via electrodes placed outside and under the scalp can safely and effectively reduce seizure frequency and intensity. Participants include epilepsy patients who haven't responded adequately to medication and aren't eligible for surgery. By precisely tuning stimulation parameters and timing stimulation to specific seizure patterns detected by EEG monitoring, the study seeks to optimize this technique for therapeutic use. The goal is to establish safety and feasibility of this minimally invasive stimulation approach, as well as to achieve preliminary efficacy data thorugh the reduction of seizure durations.

Detailed description

This clinical trial focuses on evaluating the safety, tolerability, and effectiveness of Intersectional Short Pulse (ISP) electrical stimulation in epilepsy patients. As a secondary outcome, the efficacy of ISP for reducing epileptic seizure duration and severity is also assessed. The ISP method utilizes electrodes implanted subcutaneously beneath the scalp, guided by MRI imaging for precise targeting. The trial encompasses the following phases: * Obtaining informed consents * MRI scans are conducted to personalize electrode placement based on head anatomy. * Electrodes are surgically implanted under general anesthesia. * Following implantation, continuous EEG monitoring captures baseline seizure activity. * Patients participate in stimulation tests to confirm tolerable ISP parameters. * Patients participate in stimulation tests to confirm the feasibility of ISP stimulation triggered by epileptic seizures. An advanced seizure-detection algorithm (with close supervision) triggers stimulation to target seizures at their onset either, aiming to prevent their progression. * Safety and tolerability are continuously assessed through clinical observations and participant feedback. * Possible acute effects of ISP stimulation (i.e. reduction of seizure severity and duration or stopping seizures entirely) are also recorded as secondary outcomes. * After concluding data recording, electrodes are explanted and the patients are emitted. * Follow-up evaluations ensure long-term safety and monitor ongoing seizure activity post-treatment. * Data processing: EEG data is rigorously analyzed, comparing seizure duration, severity and frequency before and after stimulation.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DEVICE	Intersection short-pulse (ISP) stimulation	The intervention aims to terminate pathological brain oscillations (i.e. epileptiform activity) in patients.

Timeline

• Start date: 2021-11-15
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-06-27
• Last updated: 2025-07-03

Locations

1 site across 1 country: Hungary