Abstract

Background: Autism spectrum disorder (ASD) is associated with anxiety and sleep problems. We investigated transdermal electrical neuromodulation (TEN) of the cervical nerves in the neck as a safe, effective, comfortable and non-pharmacological therapy for decreasing anxiety and enhancing sleep quality in ASD. Methods: In this blinded, sham-controlled study, seven adolescents and young adults with high-functioning ASD underwent five consecutive treatment days, one day of the sham followed by four days of subthreshold TEN for 20 min. Anxiety-provoking cognitive tasks were performed after the sham/TEN. Measures of autonomic nervous system activity, including saliva α-amylase and cortisol, electrodermal activity, and heart rate variability, were collected from six participants. Results: Self-rated and caretaker-rated measures of anxiety were significantly improved with TEN treatment as compared to the sham, with effect sizes ranging from medium to large depending on the rating scale. Sleep scores from caretaker questionnaires also improved, but not significantly. Performance on two of the three anxiety-provoking cognitive tasks and heart rate variability significantly improved with TEN stimulation as compared to the sham. Four of the seven (57%) participants were responders, defined as a ≥ 30% improvement in self-reported anxiety. Salivary α-amylase decreased with more TEN sessions and decreased from the beginning to the end of the session on TEN days for responders. TEN was well-tolerated without significant adverse events. Conclusions: This study provides preliminary evidence that TEN is well-tolerated in individuals with ASD and can improve anxiety.

Highlights

  • This article is an open access articleAutism spectrum disorder (ASD) is a behaviorally defined neurodevelopmental disorder with lifelong consequences that affects children during critical times in their lives [1].The Centers for Disease Control and Prevention (CDC) estimates that ASD affects about2% of children (1 in 54) in the United States (US) [2]

  • transdermal electrical neuromodulation (TEN) is a well-tolerated method for subthreshold neurostimulation that is FDAapproved for brain-based disorders such as ADHD [46] and migraines [47], and appears to have some effectiveness in major depressive disorder [42], post-traumatic stress disorder [48] and generalized anxiety disorder [49]

  • Given the cutoff for anxiety is 25 for the SCARED, these results demonstrate that TEN had a clinically significant improvement in anxiety on the group level

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Summary

Introduction

This article is an open access articleAutism spectrum disorder (ASD) is a behaviorally defined neurodevelopmental disorder with lifelong consequences that affects children during critical times in their lives [1].The Centers for Disease Control and Prevention (CDC) estimates that ASD affects about2% of children (1 in 54) in the United States (US) [2]. Autism spectrum disorder (ASD) is a behaviorally defined neurodevelopmental disorder with lifelong consequences that affects children during critical times in their lives [1]. The Centers for Disease Control and Prevention (CDC) estimates that ASD affects about. Behavioral therapy can be effective if distributed under the terms and conditions of the Creative Commons. Started early in life [3,4], only a minority of children obtain optimal outcomes [5,6] and most require lifelong supportive care [7]. The economic burden of intense and continuous educational, medical and social support is impressive [8], with the lifetime social costs to date in the US estimated to be more than $7 trillion [9]. The child’s disability creates a spillover effect that decreases the quality of life of the entire family [10,11,12]

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