NCT05469373 · Sarah Katie Ihnen
ESIS in Pediatric DRE
What this study is about
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.
View original scientific description
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).
Primary outcome measures
Safety -- Occurrence of generalized, convulsive and prolonged seizures
Time frame: Phase II epilepsy surgery testing
Evaluate the safety of ESIS in pediatric DRE patients.
Tolerability -- Quantify study withdrawal and patient/caregiver experience
Time frame: during Phase II epilepsy surgery testing
Evaluate the tolerability of ESIS in pediatric DRE patients.
Yield -- Rate of induction of habitual seizures
Time frame: during Phase II epilepsy surgery testing
Evaluate the yield of ESIS in pediatric DRE patients.
Clinical Validity
Time frame: during Phase II epilepsy surgery testing and through study completion, an average of 1 year
Test the clinical validity of ESIS in pediatric DRE patients by examining the impact of occurance of induced seizures on surgical outcomes.
Predictors
Time frame: during Phase II epilepsy surgery testing
Investigate the methodologic, anatomic, and patient-specific predictors of induced seizures in pediatric DRE patients.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Cincinnati, Ohio
Collaborators
Network for Excellence in Neuroscience Clinical Trials, Child Neurologist Career Development Program
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 23, 2025 · Source of record for eligibility and locations