Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of 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.

Inclusion criteria

• Written informed consent
• Age: between 7 and 26 years
• Participants and parent/ guardian must have proficiency in English
• Diagnosis of ASD as defined by ADOS-2 or DSM-5 criteria

Exclusion criteria

• Severe psychiatric disorders (e.g. bipolar, major depressive disorder)
• Severe neurological disorders (e.g. stroke, epilepsy)
• Bradyarrhythmia
• History of head trauma (surgery or tumor)
• Active medical implants (cochlear, VNS or pacemakers)
• Cerebral shunts
• Auricular skin disease that compromises placement of electrodes
• Pregnancy