The Clinical Research Landscape of Pediatric Drug-Resistant Epilepsy.

Abstract

To characterize the clinical research landscape of pediatric drug-resistant epilepsy (DRE) with a focus on neurotechnology. We searched the ClinicalTrials.gov registry using the terms "epilepsy" and "drug resistant" for studies including participants age 0-17 years. Returns were grouped by intervention (eg, neurotechnological, drug). Key trial features such as age range, trial status and outcomes were compared across interventions. We identified 101 registered trials with pediatric DRE patients. Thirty-two (32%) investigate neurotechnological interventions, devices, or diagnostic procedures; 13 (41%) are currently active. Among neurotechnology trials, 15 (46%) investigate vagus nerve stimulation, transcranial direct current stimulation, or deep brain stimulation; few are specific to children. Of the remaining 69 trials, 37 investigate a drug, 17 investigate a dietary therapy, and 15 investigate another intervention. Seizure frequency is the most frequent primary outcome measured in the trials identified. The landscape of registered trials pertaining to pediatric DRE reflects a lag between clinical research and clinical practice, and highlights the need for timely evidence before novel neurotechnological interventions are widely adopted into clinical practice.