High-Frequency Transdermal Neuromodulation to Decrease Anxiety and Improve Sleep in ASD

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 20 young adults, between the ages of 10 years to 25 years, with
confirmed ASD and anxiety and sleep quality issues. All patients will undergo a one day sham
stimulation session, which will be used to exclude placebo responders and those cannot
tolerate study procedures. Additionally, the visit will serve as the baseline day to collect
anxiety measures.The participants will then spend one week wearing a sleep actigraphy device
to collect 7 days of baseline sleep measures. In the second week, the participants will
return for 4 consecutive days of open label TEN stimulation treatment, while continuing to to
wear the sleep actigraphy device on a nightly basis. Participation will conclude with a one
day follow-up visit one week from the last treatment day. Anxiety will be measured primarily
using physiological data from galvanic skin response (GSR) and heart rate variability (HRV).
Secondary measures will include data from behavioral surveys and cortisol and amylase
analysis from a buccal swab. Sleep quality will be measured primarily using the data from the
sleep actigraphy. Secondary measures will include responses from a questionnaire.

Inclusion Criteria:

- IQ > 80, to be evaluated during the screening visit using the Kaufman Brief
Intelligence Test (KBIT)

- Self-reported complaints about anxiety and/or sleep issues

- Screen for Child Anxiety Related Disorders (SCARED) - Parent Form, score >= 25

- Able to follow directions in English

Exclusion Criteria:

- IQ ≤ 80, to be evaluated during the screening visit using the KBIT

- SCARED - Parent Form, Score < 25

- Has a medical implant (such as a pacemaker, cochlear implant, brain stimulation
device, spinal stimulator)

- History of significant face/head injury including cranial or facial metal plate or
screw implants

- Pregnant

- History of migraines or frequent headaches (more than once a week)

- Started taking anti-anxiety medications less than 3 months prior to study
participation or has not been taking anti-anxiety medications consistently for at
least 3 months prior to study participation

- Fainting (vaso-vagal syncope or neurocardiogenic syncope)

- Diagnosis of Raynaud's disease

- Temporomandibular joint (TMJ) disorder or other facial neuropathy

- Poor vision or hearing that is uncorrectable

- Seizures in the last 2 years

- Evidence of skin disease or skin abnormalities affecting the neck or upper back

- Upper extremity contractures