Subcutaneous Intersectional Short Pulse Stimulation in Epileptic Patients
ConditionEpilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSemmelweis University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Intersection short-pulse (ISP) stimulation
DeviceThe intervention aims to terminate pathological brain oscillations (i.e. epileptiform activity) in patients.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Single Arm: Stimulation of pathological epileptiform brain activityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Automatically Detected Seizures Successfully Treated with Closed-loop Subgaleal ISP Stimulation [Feasibility]
Intervention delivery rate (success rate of demonstrating the deliverability of the method as designed in the patient population, i.e. automatic seizure detection followed by ictal stimulation by subgaleal ISP stimulation)
Time frame
From enrollment to the end of treatment at maximum 12 weeks2
Incidence and Severity of Treatment-Emergent Adverse Events of Subgaleal ISP stimulation [Safety]
Frequency (number) and severity (graded mild, moderate, severe) of all adverse events experienced by each patient during the treatment period.
Time frame
From enrollment to the end of treatment at maximum 12 weeks3
Level of Subjective Discomfort associated with of subgaleal ISP stimulation [Tolerability]
Patient-reported subjective perception of stimulation intensity recorded on a Visual Analog Scale (VAS), ranging from 0 (no discomfort) to 10 (maximum discomfort). Higher scores indicate greater discomfort and worse tolerability.
Time frame
From enrollment to the end of treatment at maximum 12 weeksSecondary outcomes
1
Efficacy of seizure termination by subgaleal ISP stimulation
Percent decrease in average seizure duration between stimulated (i.e. treated) and non-stimulated (i.e. control) seizures
Time frame
From enrollment to the end of treatment at maximum 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Semmelweis University
Lead sponsor
Neunos ZRt
Collaborator
Source ClinicalTrials.gov