Subcutaneous Intersectional Short Pulse Stimulation in Epileptic Patients

NCT07041619 | Recruiting

• 1 other identifier: OGYÉI/9674/2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (3)

• Percentage of Automatically Detected Seizures Successfully Treated with Closed-loop Subgaleal ISP Stimulation [Feasibility]

  Intervention delivery rate (success rate of demonstrating the deliverability of the method as designed in the patient population, i.e. automatic seizure detection followed by ictal stimulation by subgaleal ISP stimulation)

  From enrollment to the end of treatment at maximum 12 weeks

• Incidence and Severity of Treatment-Emergent Adverse Events of Subgaleal ISP stimulation [Safety]

  Frequency (number) and severity (graded mild, moderate, severe) of all adverse events experienced by each patient during the treatment period.

  From enrollment to the end of treatment at maximum 12 weeks

• Level of Subjective Discomfort associated with of subgaleal ISP stimulation [Tolerability]

  Patient-reported subjective perception of stimulation intensity recorded on a Visual Analog Scale (VAS), ranging from 0 (no discomfort) to 10 (maximum discomfort). Higher scores indicate greater discomfort and worse tolerability.

  From enrollment to the end of treatment at maximum 12 weeks

Secondary Outcomes (1)

• Efficacy of seizure termination by subgaleal ISP stimulation

  From enrollment to the end of treatment at maximum 12 weeks

Study Arms (1)

Single Arm: Stimulation of pathological epileptiform brain activity

EXPERIMENTAL

Device: Intersection short-pulse (ISP) stimulation

Interventions

Intersection short-pulse (ISP) stimulation DEVICE

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

Single Arm: Stimulation of pathological epileptiform brain activity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Semmelweis University: lead
• Neunos ZRt: collaborator

Study Sites (1)

Semmelweis University Neurosurgery and Neurointerventional Clinic

Budapest, 1145, Hungary

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 27, 2025
• Study Start: November 15, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

HU (1)