An interventional study of vagus nerve stimulation in Autism Spectrum Disorder, sponsored by Neuropix. Recruiting at 1 site in Hong Kong. Open to participants aged 7 Years to 26 Years. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Neuropix · Not applicable, Interventional, and Device feasibility
Non-invasive vagus nerve stimulation for the symptomatic improvements in Autism Spectrum Disorder
A single arm open-label study in Autism Spectrum Disorder (ASD) for evaluating treatment effects of non-invasive VNS, specifically auricular fiber vagal nerve stimulation (afVNS). A total of 20 patients diagnosed with ASD will be recruited to evaluate the feasibility of home healthcare application of afVNS and for assessment of short-term treatment effects on symptoms and comorbidities. ASD patients will receive 1 x hour per day afVNS treatment over 14 days with a fixed neuromodulation protocol. The primary outcome measure is feasibility assessed from completion success and neurostimulation tolerance. Secondary outcome measures include changes in scores pre- and post- afVNS treatment for Clinician Global Clinical Impression (CGI-I), Clinician Global Impression Severity (CGI-S), Children's Anxiety Sensitivity Index (CASI-R), Parent-Rated Anxiety Scale for ASD (PRAS-ASD), Autistic Behavior Checklist (ABC), Cleveland Adolescent Sleep Questionnaire (CASQ), verbal fluency and biomarker measures in autonomic physiology.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's planned enrollment of 20 is below the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →This is the only study on the registry with Neuropix as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Receiving intervention of the non-invasive neurostimulation device.
Device: vagus nerve stimulation
Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS)
Feasibility for completed treatments and stimulation intensity tolerance
Completion success and neurostimulation tolerance
Time frame: 2 weeks
Clinician Global Clinical Impression (CGI-I)
For core social impairment and overall level of cognitive, adaptive and social functioning
Time frame: 2 weeks
Clinician Global Impression Severity (CGI-S)
For assessment of anxiety, gastrointestinal symptoms and social interactions and overall ASD
Time frame: 2 weeks
Parent-Rated Anxiety Scale for ASD (PRAS-ASD)
For anxiety assessment consisting of 25 questions related to anxiety ranging from 0 (none) to 3 (severe)
Time frame: 2 weeks
Autistic Behavior Checklist (ABC) scores
For measurements of 5 behavioral domains including irritability, social withdrawal, stereotypy, hyperactivity and inappropriate speech
Time frame: 2 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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