Pilot Feasibility Study of Cranial Electrotherapy Stimulation (CES) on Behavioral Regulation in a Mixed Clinical Cohort

Abstract

Objective: Children and adolescents with neurodevelopmental disorders often report disturbances in autonomic nervous system (ANS) related behavioral regulation such as sensory sensitivity, anxiety, and emotion dysregulation. Cranial electrotherapy stimulation (CES) is a method of non-invasive transcranial current stimulation presumed to modify behavioral regulation abilities via ANS modulation. Methods: To begin to address this knowledge gap, we examined the feasibility and preliminary efficacy of a 4-week CES intervention on behavioral regulation in a mixed neurodevelopmental sample of children and adolescents currently receiving care at clinical centers operated by Cortica. We first aimed to evaluate adherence, side effects, and tolerance of CES device use. Second, we aimed to evaluate pre-post change in three PNS-associated behavioral regulation conditions: sensory sensitivities, emotion dysregulation, and anxiety. Results: Feasibility results demonstrated moderate adherence, tolerability, and satisfaction with CES usage. Further, preliminary efficacy results demonstrated a significant reduction in sensory sensitivity, anxiety, and emotion dysregulation. Conclusion: Results from this pilot study provide justification for future randomized control trials using CES in children and adolescents with behavioral dysregulation.