An Open-Label Study of Cranial Electrotherapy Stimulation on Behavioral Regulation in a Mixed Neurodevelopmental Clinical Cohort

• Published in: Journal of integrative neuroscience 2023-08, Vol.22 (5), p.119-119
• Main Authors: Brandes-Aitken, Annie, Gerdes, Molly, Hattangadi, Neil, Shapiro, Kevin A., Marco, Elysa J.
• Format: Article
• Language: English
• Subjects: anxiety; cranial electrotherapy stimulation; emotion regulation; neurodevelopment; sensory sensitivity
• ISSN: 0219-6352
• DOI: 10.31083/j.jin2205119

OBJECTIVEIndividuals with neurodevelopmental disorders often report disturbances in the 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 neuromodulation presumed to modify behavioral regulation abilities via ANS modulation. Here we examined the feasibility and preliminary effects of a 4-week CES intervention on behavioral regulation in a mixed neurodevelopmental cohort of children, adolescents, and young adults. METHODSIn this single-arm open-label study, 263 individuals aged 4-24 who were receiving clinical care were recruited. Participants received at-home CES treatment using an Alpha-Stim® AID CES device for 20 minutes per day, 5-7 days per week, for four weeks. Before and after the intervention, a parent-report assessment of sensory sensitivities, emotion dysregulation, and anxiety was administered. Adherence, side effects, and tolerance of the CES device were also evaluated at follow-up. RESULTSResults showed a 75% completion rate, an average tolerance score of 68.2 (out of 100), and an average perceived satisfaction score of 58.8 (out of 100). Additionally, a comparison between pre- and post-CES treatment effects showed a significant reduction in sensory sensitivity, anxiety, and emotion dysregulation in participants following CES treatment. CONCLUSIONSResults provide justification for future randomized control trials using CES in children and adolescents with behavioral dysregulation. SIGNIFICANCECES may be a useful therapeutic tool for alleviating behavioral dysregulation symptoms in children and adolescents with neurodevelopmental differences.