Subcutaneous intersectional short-pulse brain stimulation for epilepsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study implants MRI-guided, subcutaneous electrodes beneath the scalp and uses ultra-brief, distributed ISP pulses to concentrate electric fields on targeted brain areas while limiting effects on surrounding tissue. After implantation, patients undergo continuous EEG to capture baseline seizures and to test tolerable stimulation parameters. An automated seizure-detection algorithm (with close clinical supervision) triggers ISP at seizure onset to try to prevent progression, while safety and tolerability are continuously monitored. Electrodes are removed after data collection and patients receive follow-up assessments to document any lasting effects or adverse events.

Why it matters

Who can join: the full rules

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's running

• Semmelweis University Neurosurgery and Neurointerventional Clinic
  Budapest, Hungary Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.