ESIS in Pediatric DRE

Epilepsy Clinical Trial

Official title:

Electrical Stimulation for Seizure Induction in Pediatric Drug-Refractory Epilepsy (ESIS in Pedriatric DRE).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05469373
• Other study ID #: 2022-0020
• Status: Recruiting
• Start date: February 17, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: August 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Sarah Katie Ihnen, MD, PhD
• Phone: 5136364222
• Email: Katie.Ihnen[@]cchmc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main reason for this research study is to gain information about how the brain makes seizures by causing seizures using very small amounts of current, or electrical stimulation. Using small amounts of current to cause seizures (or stimulate) is not new at CCHMC - it is part of routine clinical practice for some patients at some electrodes.

This study differs from routine clinical care in that all study patients will undergo electrical stimulation in all or nearly all electrode contacts. The study team is doing this because there is promising data in adult patients that stimulating comprehensively (targeting all or nearly all of the electrode contacts) helps define the seizure network. Defining the seizure network in turn helps the medical team plan surgery. So far, there is not as much published data on seizure stimulation for pediatric patients.

This research study thus has the potential both to help individual patients (by providing specific information about your seizure networks) and to help pediatric patients with epilepsy in general (by increasing our understanding of stimulated seizures in children, teenagers and young adults).

Description:

Epilepsy affects about 1% of the population, with roughly 30% of patients with epilepsy eventually developing drug-resistant epilepsy (DRE). Increasingly, surgery is pursued for DRE, yielding seizure freedom rates of 50-70%. However, accurate deduction of the epileptogenic zone (EZ) for surgical planning can be difficult in pediatric DRE, especially in those cases of multifocal seizures, as is often seen in Tuberous Sclerosis Complex (TSC), for example. Patients with multifocal epilepsy typically require a period of pre-surgical invasive EEG monitoring to record spontaneous seizures, the gold standard for EZ deduction. Unfortunately, the invasive monitoring process may be lengthy, costly and even fail to reveal a dominant EZ.

Electrical stimulation of induced seizures (ESIS) using stereo EEG (sEEG) has been shown to be a safe and valid adjunct for EZ delineation in adults with DRE. ESIS can be implemented within 1-2 days of electrode implantation, while the patient would otherwise be passively awaiting spontaneous seizures. ESIS typically induces habitual seizures with few side effects, and there is no data to suggest that ESIS inhibits spontaneous seizures or prolongs the otherwise clinically-indicated hospital stay. Crucially, published data show that induced seizures provide information about the EZ that is both convergent with and unique from that provided by spontaneous seizures. Despite these promising reports, ESIS is not widely integrated into pediatric DRE evaluation.

The overall objective is to improve methods of EZ identification in pediatric DRE patients with complex EZs, thereby increasing the likelihood of surgical candidacy for patients and ultimately improving surgical outcomes. In this protocol, investigators hypothesize that electrical stimulation of induced seizures (ESIS) is an effective adjunct for EZ delineation in children with DRE. To test this, the study will enroll n=86 patients with DRE undergoing sEEG evaluation aged 1-30 years. Based on the CCHMC epilepsy surgery program throughput, it is anticipated that this will include approximately n=36 patients with TSC and n=50 without TSC, which will provide the opportunity to compare the utility of this technique between patients with and without TSC. Patients will undergo ESIS using published Cincinnati Children's Hospital Medical Center (CCHMC) parameters with modifications. Gray and white matter contacts will be stimulated systematically. Safety, tolerability, yield, validity and parameter space will be examined.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 31, 2027
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 30 Years

Eligibility

Inclusion Criteria:

• Diagnosis of drug-refractory epilepsy (DRE)

• 1-30 years of age

• recommended to undergo stereoencephalography (sEEG) at CCHMC

Exclusion Criteria:

• <1 and >30 years of age

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Sarah Katie Ihnen	Child Neurologist Career Development Program, Network for Excellence in Neuroscience Clinical Trials

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety -- Occurrence of generalized, convulsive and prolonged seizures	Evaluate the safety of ESIS in pediatric DRE patients.	Phase II epilepsy surgery testing
Primary	Tolerability -- Quantify study withdrawal and patient/caregiver experience	Evaluate the tolerability of ESIS in pediatric DRE patients.	during Phase II epilepsy surgery testing
Primary	Yield -- Rate of induction of habitual seizures	Evaluate the yield of ESIS in pediatric DRE patients.	during Phase II epilepsy surgery testing
Primary	Clinical Validity	Test the clinical validity of ESIS in pediatric DRE patients by examining the impact of occurance of induced seizures on surgical outcomes.	during Phase II epilepsy surgery testing and through study completion, an average of 1 year
Primary	Predictors	Investigate the methodologic, anatomic, and patient-specific predictors of induced seizures in pediatric DRE patients.	during Phase II epilepsy surgery testing