Recruiting

ESIS

Sponsor:

Sarah Katie Ihnen

Code:

NCT05469373

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 1 - 30

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05469373

Start date

Feb 17, 2022

Status verified date

Dec, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 30

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

86 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Safety -- Occurrence of generalized, convulsive and prolonged seizures [ Time Frame: Phase II epilepsy surgery testing ]
  • Tolerability -- Quantify study withdrawal and patient/caregiver experience [ Time Frame: during Phase II epilepsy surgery testing ]
  • Yield -- Rate of induction of habitual seizures [ Time Frame: during Phase II epilepsy surgery testing ]
  • Clinical Validity [ Time Frame: during Phase II epilepsy surgery testing and through study completion, an average of 1 year ]
  • Predictors [ Time Frame: during Phase II epilepsy surgery testing ]

Central Contacts and Locations

Central contacts

Sarah Katie Ihnen, MD, PhD

5136364222Katie.Ihnen@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

More Information

Sponsor

Sarah Katie Ihnen

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Keywords

  • epilepsy surgery, drug-resistant epilepsy, tuberous sclerosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sarah Katie Ihnen on 2025-12-23.