Clinical trial · Observational
ESIS in Pediatric DRE
Electrical Stimulation for Seizure Induction in Pediatric Drug-Refractory Epilepsy (ESIS in Pedriatric DRE).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epilepsy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Safety -- Occurrence of generalized, convulsive and prolonged seizures
- timeFrame
- Phase II epilepsy surgery testing
- description
- Evaluate the safety of ESIS in pediatric DRE patients.
- measure
- Tolerability -- Quantify study withdrawal and patient/caregiver experience
- timeFrame
- during Phase II epilepsy surgery testing
- description
- Evaluate the tolerability of ESIS in pediatric DRE patients.
- measure
- Yield -- Rate of induction of habitual seizures
- timeFrame
- during Phase II epilepsy surgery testing
- description
- Evaluate the yield of ESIS in pediatric DRE patients.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available