Subcutaneous Intersectional Short Pulse Stimulation in Epileptic Patients

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.

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