The Clinical Research Landscape of Pediatric Drug-Resistant Epilepsy

J Child Neurol. 2020 Oct;35(11):763-766. doi: 10.1177/0883073820931255. Epub 2020 Jun 16.

Abstract

Objective: To characterize the clinical research landscape of pediatric drug-resistant epilepsy (DRE) with a focus on neurotechnology.

Method: 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.

Results: 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.

Significance: 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.

Keywords: clinical trials; drug-resistant epilepsy; neurotechnological interventions.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Clinical Trials as Topic
  • Drug Resistant Epilepsy / therapy*
  • Female
  • Humans
  • Infant
  • Male
  • Registries
  • Research Design*
  • Transcranial Direct Current Stimulation / methods*
  • Treatment Outcome
  • Vagus Nerve Stimulation / methods*