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RECRUITING
NCT07041619
NA

Subcutaneous Intersectional Short Pulse Stimulation in Epileptic Patients

Sponsor: Semmelweis University

View on ClinicalTrials.gov

Summary

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.

Official title: Changes in Brain Activity as a Function of Scalp and Subcutaneous Electrical Stimulation Parameters in Epileptic Patients

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2021-11-15

Completion Date

2027-12-31

Last Updated

2025-07-03

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Intersection short-pulse (ISP) stimulation

The intervention aims to terminate pathological brain oscillations (i.e. epileptiform activity) in patients.

Locations (1)

Semmelweis University Neurosurgery and Neurointerventional Clinic

Budapest, Hungary