Daily non-invasive ear vagus nerve stimulation for autism
Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder: An Open-Label Trial
This will test whether daily non-invasive ear (auricular) vagus nerve stimulation helps children and young adults with autism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 7 Years to 26 Years |
| Sex | All |
| Sponsor | Neuropix Industry-sponsored |
| Locations | 1 site (Tai Po) |
| Trial ID | NCT06473623 on ClinicalTrials.gov |
What this trial studies
This is a single-arm, open-label feasibility study enrolling 20 participants aged 7–26 with ASD. Participants will receive one hour per day of auricular fiber vagus nerve stimulation at home for 14 days using a fixed neuromodulation protocol, with initial training and monitoring by study staff. The primary outcome is feasibility measured by completion rates and tolerance, and secondary outcomes include clinician- and parent-rated symptom scales, sleep and verbal fluency measures, and autonomic biomarker changes. The study aims to see if short-term home-administered afVNS is practical and produces measurable symptom or physiological changes.
Who should consider this trial
Good fit: Ideal candidates are English-speaking individuals aged 7–26 with a DSM-5 or ADOS-2 diagnosis of ASD who do not have severe psychiatric or neurological conditions or active implanted medical devices.
Not a fit: Patients with epilepsy, pacemakers or other implants, severe psychiatric disorders, recent head trauma, active ear skin disease, or pregnancy are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this could offer a non-drug option that reduces anxiety, improves sleep, and eases some autistic symptoms for some patients.
How similar studies have performed: Non-invasive auricular VNS has shown preliminary benefits in mood, epilepsy, and small neurodevelopmental studies, but its use specifically for ASD is relatively novel with limited supporting data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tai Po
- Hong Kong Science Park — Tai Po, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Daniel Ko, PhD — Neuropix
- Study coordinator: Daniel Ko, PhD
- Email: danielko@neuro-pix.com
- Phone: +85255308212
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.