Subcutaneous Intersectional Short Pulse Stimulation in Epileptic Patients

NCT ID: NCT07041619

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Single Arm: Stimulation of pathological epileptiform brain activity

Group Type: EXPERIMENTAL

Intersection short-pulse (ISP) stimulation

Intervention Type: DEVICE

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

Interventions

Intersection short-pulse (ISP) stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age between 18-65 years
• Patients with drug-resistant focal epilepsy who, after non-invasive or invasive EEG monitoring and neuropsychological, epilepsy protocol cranial MRI, or FDG-PET/CT or FDG-PET/MRI and/or ictal SPECT, have been declared unfit for resective epilepsy surgery by an interdisciplinary epilepsy team.
• Diagnosis of focal or idiopathic generalised epilepsy
• With antiepileptic drugs, 4 or more focal seizures per month, or frequent spike-wave activity on EEG - min 10 sec/hour.
• A patient who is fit to care for the wound and whose home environment this in terms of compliance and cleanliness

Exclusion Criteria

• subjects under 18 years old
• If the patient is suitable for resective surgery or if there are questions about the patient's suitability for resective surgery of autoimmune aetiology
• Progressive brain lesions on MRI or a serious internal organ disease or coagulopathy considered serious by your doctor
• Subjects who have an electrical energy transmitting implant implanted in the brain or other organ(s), including pacemakers, intracardiac defibrillators and any device meeting this definition
• Pregnancy. Pregnancy should be checked by a pregnancy test for all women of childbearing potential
• Previous traumatic brain and skull injury, stroke are not exclusionary, but in all such cases the examining physician and the Neunos technical support team should be consulted
• The presence of metal implants is generally considered contraindicated. In all such cases, the investigating physician or the Neunos technical support team should be consulted

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neunos ZRt

INDUSTRY

Sponsor Role: collaborator

Semmelweis University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Semmelweis University Neurosurgery and Neurointerventional Clinic

Budapest, , Hungary

Site Status: RECRUITING

Countries

Hungary

Facility Contacts

Principal Investigator

Role: primary

titkarsag.amerikaiut@semmelweis.hu

+3614679301

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OGYÉI/9674/2021

Identifier Type: -

Identifier Source: org_study_id