Actively Recruiting
Subcutaneous Intersectional Short Pulse Stimulation in Epileptic Patients
Led by Semmelweis University · Updated on 2025-07-03
30
Participants Needed
1
Research Sites
319 weeks
Total Duration
On this page
Sponsors
S
Semmelweis University
Lead Sponsor
N
Neunos ZRt
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Subcutaneous Intersectional Short Pulse Stimulation in Epileptic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18-65 years
- Patients with drug-resistant focal epilepsy declared unfit for epilepsy surgery by an interdisciplinary team after thorough evaluation
- Diagnosis of focal or idiopathic generalized epilepsy
- Experiencing 4 or more focal seizures per month or frequent spike-wave EEG activity (minimum 10 seconds per hour) while on antiepileptic drugs
- Able to care for the wound and maintain a compliant, clean home environment
You will not qualify if you...
- Under 18 years of age
- Suitable for resective surgery or uncertain suitability for surgery due to autoimmune causes
- Progressive brain lesions on MRI or serious internal organ disease or coagulopathy considered serious by a doctor
- Implanted electrical energy transmitting devices in the brain or other organs, including pacemakers and defibrillators
- Pregnancy (must be checked by pregnancy test for women of childbearing potential)
- Presence of metal implants generally contraindicated unless approved by physician or technical support
- Previous traumatic brain or skull injury and stroke require consultation with physician and technical support
AI-Screening
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Trial Site Locations
Total: 1 location
1
Semmelweis University Neurosurgery and Neurointerventional Clinic
Budapest, Hungary, 1145
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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