High-Frequency Transdermal Neuromodulation to Decrease Anxiety and Improve Sleep in ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The objective of this study is to investigate the feasibility of cervical TEN stimulation
      (TENS) delivered to the back of the neck to decrease anxiety and sleep issues in young adults
      with Autism Spectrum Disorder (ASD). The specific aim is to determine the effect of TENS,
      delivered over 3 daily sessions, on anxiety and sleep quality in young adults with ASD, as
      compared to sham and baseline. The investigator will enroll up to 10 young adults, aged 10 to
      25 years of age with confirmed ASD and measureable anxiety and sleep disturbance symptoms,
      and participation will last 3 weeks.
    

Detailed description: 
      Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental disorder with life-long
      consequences that affects children during critical times in their development. ASD is
      associated with co-occurring problems such as anxiety and sleep disturbances. New approaches
      to managing stress, anxiety, and sleep quality would greatly enhance the quality of life and
      activities of daily living for children with ASD as they transition to adulthood and age out
      of services. Based on strong evidence from typically developing individuals, the technology
      for transdermal electrical neuromodulation (TEN) of the cranial nerves has shown to be a
      safe, effective, comfortable, and non-pharmacological therapy to modulate the central nervous
      system decreasing anxiety and enhancing sleep quality to improve the quality of life for
      people with ASD.

      The therapy applies tuned, high-frequency TEN to the back of the neck which activates the
      brainstem modulating noradrenergic signaling shown to decrease anxiety in healthy adults. The
      low-amplitude of the stimulation means that it is painless and comfortable. Furthermore, the
      technology is being evaluated for improving sleep quality. The mechanism of these effects are
      well established in the neurophysiology literature, but modulating these brainstem areas is
      only now possible non-invasively with the technology. Participants entered into the trial wil
      have anxiety and sleep issues that are known to be associated with ASD. The investigators
      hypothesize that cervical TEN will decrease anxiety and improve sleep quality in a population
      with high-functioning ASD who are transitioning into adulthood.

      The investigators will study 10 young adults, between the ages of 10 years to 25 years, with
      confirmed ASD and anxiety and sleep quality issues. All participants will be enrolled in the
      study for approximately 2 weeks. During the first week, participants will undergo 5
      consecutive days of stimulation. On Visit 1, all participants will receive sham stimulation,
      which will be used to exclude placebo responders and those who cannot tolerate study
      procedures, and determine the maximum stimulation threshold for eligible participants.
      Additionally, the visit will serve as the baseline day to collect measures of anxiety. The
      primary physiological anxiety measures include galvanic skin response (GSR) and heart rate
      variability (HRV). Secondary measures will include data from behavioral surveys, and cortisol
      and amylase analyses from passive drool samples. Participants will report baseline sleep
      habits in the form of a questionnaire.

      If all eligibility criteria are met, participants will return for 3 consecutive days of open
      label TEN stimulation treatment. Anxiety measures will be collected at each visit. On the
      fifth consecutive day, participants will once again receive sham stimulation in order to
      determine the impact of the open label treatment. Participation will conclude with a one day
      phone follow-up visit one week from the last treatment day. Caregivers will report
      participant sleep quality and any adverse effects or changes.
    

Intervention name(s): Transdermal Neuromodulation Stimulation
Intervention type(s): Device
Intervention description(s): The TEN device administers a tuned high frequency electrical stimulation delivered to the cervical plexus (C2-C4) on the back of the neck for 20 minutes. This stimulation will activate common trigeminovagal pathways modulating noradrenergic signaling to attenuate sympathetic activity. This stimulation can subsequently regulate the activity of several deep-brain nuclei within the ascending reticular activating system (RAS). Nuclei in the RAS regulate powerful neuromodulators like norepinephrine (NE), acetylcholine (ACh), and serotonin (5-HT). The investigators will examine whether this modulation from TENS will decrease anxiety and improve sleep quality in the study participants.
Intervention model: Single Group Assignment
Intervention model description: Prospective 3 day open-label device trial across all subjects, with 1 day single-blinded sham pre- and post-treatment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anxiety; Sleep Issues