ESIS in Pediatric DRE

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Sarah Katie Ihnen
Study ID
NCT05469373
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Study Details

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).

Key Dates

Start date
Feb 17, 2022
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
86 participants (estimated)

Primary Outcome Measure

Safety -- Occurrence of generalized, convulsive and prolonged seizures [ Time Frame: Phase II epilepsy surgery testing ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Sarah Katie Ihnen, M.D
513-636-4222
Molly S. Griffith, BA
513-636-9669

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