NCT06473623

Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder

Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder: An Open-Label Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Neuropix · Industry
• Sex: All
• Age: 7 Years – 26 Years
• Healthy volunteers: Not accepted

Summary

Non-invasive vagus nerve stimulation for the symptomatic improvements in Autism Spectrum Disorder

Detailed description

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DEVICE	vagus nerve stimulation	Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS)

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-02-01
• Completion: 2026-02-10
• First posted: 2024-06-25
• Last updated: 2026-01-08

Locations

1 site across 1 country: Hong Kong