EpilepsyNCT05469373
ESIS in Pediatric DRE
An observational study of Epilepsy, run by Sarah Katie Ihnen at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 30 years
- Conditions the study is for
- Epilepsy
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2022to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Diagnosis of drug-refractory epilepsy (DRE)
- 1-30 years of age
- recommended to undergo stereoencephalography (sEEG) at CCHMC
Who cannot join
- <1 and >30 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Electrical Stimulation for Seizure Induction in Pediatric Drug-Refractory Epilepsy (ESIS in Pedriatric DRE).
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).
Read the detailed 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.
- Conditions
- Epilepsy
- Keywords
- epilepsy surgery, drug-resistant epilepsy, tuberous sclerosis
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy, Tuberous Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety -- Occurrence of generalized, convulsive and prolonged seizures
Evaluate the safety of ESIS in pediatric DRE patients.
Measured: Phase II epilepsy surgery testing
Tolerability -- Quantify study withdrawal and patient/caregiver experience
Evaluate the tolerability of ESIS in pediatric DRE patients.
Measured: during Phase II epilepsy surgery testing
Yield -- Rate of induction of habitual seizures
Evaluate the yield of ESIS in pediatric DRE patients.
Measured: 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.
Measured: 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.
Measured: during Phase II epilepsy surgery testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start17 Feb 2022
- Primary completion1 Feb 2026
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarah Katie Ihnen
- Sponsor type
- University, hospital or other
- Collaborators
- Network for Excellence in Neuroscience Clinical Trials, Child Neurologist Career Development Program
- Responsible party
- Sponsor-investigator, Sarah Katie Ihnen, Children's Hospital Medical Center, Cincinnati
- Investigators
- Sarah Katie Ihnen, MD, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469373
- Sponsor's protocol ID
- 2022-0020
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation for Seizure Induction in Pediatric Drug-Refractory Epilepsy (ESIS in Pedriatric DRE).
- ClinicalTrials.gov ID
- NCT05469373
- Acronym / sponsor ID
- 2022-0020
- Conditions
- Epilepsy
- Keywords
- epilepsy surgery, drug-resistant epilepsy, tuberous sclerosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Sarah Katie IhnenUniversity, hospital or other
- Collaborators
- Network for Excellence in Neuroscience Clinical Trials, Child Neurologist Career Development Program
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Diagnosis of drug-refractory epilepsy (DRE)
- 1-30 years of age
- recommended to undergo stereoencephalography (sEEG) at CCHMC
Key exclusion criteria (1 listed)
- <1 and >30 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Katie Ihnen, MD, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Sarah Katie Ihnen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety -- Occurrence of generalized, convulsive and prolonged seizures (time frame: Phase II epilepsy surgery testing). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.