NCT07041619Recruiting
Subcutaneous Intersectional Short Pulse Stimulation in Epileptic Patients
Changes in Brain Activity as a Function of Scalp and Subcutaneous Electrical Stimulation Parameters in Epileptic Patients
Source: ClinicalTrials.gov · Last updated 3 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 10 Jun 2025
- Start date
- 15 Nov 2021
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Semmelweis University
- Diseases
- Epilepsy
- NCT number
- NCT07041619
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 15 Nov 2021 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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
Age
- subjects under 18 years old
Other
- Pregnancy. Pregnancy should be checked by a pregnancy test for all women of childbearing potential
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Semmelweis University Neurosurgery and Neurointerventional Clinic Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.