ESIS in Pediatric DRE

NCT05469373 | Recruiting DMC

• 1 other identifier: 2022-0020
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Epilepsy

Keywords

epilepsy surgery, drug-resistant epilepsy, tuberous sclerosis

Outcome Measures

Primary Outcomes (5)

• Safety -- Occurrence of generalized, convulsive and prolonged seizures

  Evaluate the safety of ESIS in pediatric DRE patients.

  Phase II epilepsy surgery testing

• Tolerability -- Quantify study withdrawal and patient/caregiver experience

  Evaluate the tolerability of ESIS in pediatric DRE patients.

  during Phase II epilepsy surgery testing

• Yield -- Rate of induction of habitual seizures

  Evaluate the yield of ESIS in pediatric DRE patients.

  during Phase II epilepsy surgery testing

• 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

• Predictors

  Investigate the methodologic, anatomic, and patient-specific predictors of induced seizures in pediatric DRE patients.

  during Phase II epilepsy surgery testing

Eligibility Criteria

• Age: 1 Year - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants with drug-refractory epilepsy who receive care at or are referred into the CCHMC Comprehensive Epilepsy Center will comprise the targeted study population. Specifically, those patients who undergo phase I evaluations and are subsequently recommended for phase II evaluations at CCHMC will be identified as research study candidates.

You may qualify if:

• Diagnosis of drug-refractory epilepsy (DRE)
• years of age
• recommended to undergo stereoencephalography (sEEG) at CCHMC

You may not qualify if:

• \<1 and \>30 years of age

Sponsors & Collaborators

• Sarah Katie Ihnen: lead
• Network for Excellence in Neuroscience Clinical Trials: collaborator
• Child Neurologist Career Development Program: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy; Drug Resistant Epilepsy; Tuberous Sclerosis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hamartoma; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Sarah Katie Ihnen, MD, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Katie Ihnen, MD, PhD

CONTACT

5136364222; Katie.Ihnen@cchmc.org

Molly S Griffith, BA

CONTACT

15136369669; molly.griffith@cchmc.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty, Research Instructor

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 21, 2022
• Study Start: February 17, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)