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

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

May 21, 2019

Primary Completion Date

July 19, 2021

Study Completion Date

October 6, 2021

Conditions
Autism Spectrum Disorder
Interventions
DEVICE

Transdermal Neuromodulation Stimulation

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.

Trial Locations (1)

85016

Phoenix Children's Hospital, Phoenix

All Listed Sponsors
lead

Phoenix Children's Hospital

OTHER

NCT03859336 - High-Frequency Transdermal Neuromodulation to Decrease Anxiety and Improve Sleep in ASD | Biotech Hunter | Biotech Hunter