Subcutaneous Intersectional Short Pulse Stimulation in Epileptic Patients
Recruiting · NCT07041619 · Interventional (participants receive a specific treatment) · Lead sponsor: Semmelweis University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
1 location listed.
- Semmelweis University Neurosurgery and Neurointerventional Clinic - Budapest, Hungary