An interventional study of Intersection short-pulse (ISP) stimulation in Epilepsy, sponsored by Semmelweis University. Recruiting at 1 site in Hungary. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Semmelweis University · Not applicable, Interventional, and Device feasibility
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.
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:
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Semmelweis University is the lead sponsor of 136 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Intersection short-pulse (ISP) stimulation
The intervention aims to terminate pathological brain oscillations (i.e. epileptiform activity) in patients.
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 weeks
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 weeks
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 weeks
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 weeks
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Semmelweis University