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NCT07041619

Subcutaneous Intersectional Short Pulse Stimulation in Epileptic Patients

Recruiting now NA Last updated 3 July 2025
What this trial tests

NA trial testing Intersection short-pulse (ISP) stimulation in Epilepsy in 30 participants. Currently enrolling.

Timeline
15 November 2021
Primary endpoint
31 December 2027
31 December 2027

Quick facts

Lead sponsorSemmelweis University
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposedevice feasibility
Enrollment30
Start date15 November 2021
Primary completion31 December 2027
Estimated completion31 December 2027
Sites1 location across Hungary

Drugs / interventions tested

Conditions studied

Sponsor

Semmelweis University

Who can join

Adults 18 to 65, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Closed-Loop, Subgaleal Intersectional Short-Pulse Stimulation for the Treatment of Therapy-Resistant Epilepsy in Adults
    Chadaide Z, Fabó D, Szoboszlay M, Barcsai L, et al · · 2025 · DOI 10.1101/2025.09.27.25334859

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Other recruiting trials for Epilepsy

Currently open trials in the same condition.

Other Semmelweis University trials

Trials by the same sponsor.

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