Subcutaneous intersectional short-pulse brain stimulation for epilepsy
Changes in Brain Activity as a Function of Scalp and Subcutaneous Electrical Stimulation Parameters in Epileptic Patients
NA · Semmelweis University · NCT07041619
This trial tries a new subcutaneous intersectional short-pulse (ISP) electrical stimulation system to see if it can safely reduce seizure frequency and severity in adults with drug-resistant epilepsy who are not candidates for surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Semmelweis University (other) |
| Locations | 1 site (Budapest) |
| Trial ID | NCT07041619 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–65 with drug-resistant focal epilepsy who are not suitable for resective surgery, experience four or more focal seizures per month (or frequent EEG spike activity), and can manage wound care at home are ideal candidates.
Not a fit: Patients who are suitable for resective surgery, have progressive brain lesions or serious comorbidities or coagulopathy, are under 18, or have contraindicated implanted electrical devices or autoimmune etiologies are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, ISP could lower seizure frequency and severity and offer a less-invasive neuromodulation option for patients who cannot have resective surgery.
How similar studies have performed: Responsive neurostimulation and deep brain stimulation have reduced seizures in some patients, but ISP is a novel ultra-brief, subcutaneous approach with only early preclinical efficacy data so far.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Budapest
- Semmelweis University Neurosurgery and Neurointerventional Clinic — Budapest, Hungary (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsy