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Subcutaneous Intersectional Short Pulse Stimulation in Epileptic Patients

NCT07041619 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-03

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Intersection short-pulse (ISP) stimulation

The intervention aims to terminate pathological brain oscillations (i.e. epileptiform activity) in patients.

Sponsors & Collaborators

  • Neunos ZRt

    collaborator INDUSTRY

  • Semmelweis University

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Hungary

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07041619 on ClinicalTrials.gov