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

January 5, 2026 updated by: Neuropix

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Receiving intervention of the non-invasive neurostimulation device.
Device: vagus nerve stimulation
Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility for completed treatments and stimulation intensity tolerance
Time Frame: 2 weeks
Completion success and neurostimulation tolerance
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Global Clinical Impression (CGI-I)
Time Frame: 2 weeks
For core social impairment and overall level of cognitive, adaptive and social functioning
2 weeks
Clinician Global Impression Severity (CGI-S)
Time Frame: 2 weeks
For assessment of anxiety, gastrointestinal symptoms and social interactions and overall ASD
2 weeks
Parent-Rated Anxiety Scale for ASD (PRAS-ASD)
Time Frame: 2 weeks
For anxiety assessment consisting of 25 questions related to anxiety ranging from 0 (none) to 3 (severe)
2 weeks
Autistic Behavior Checklist (ABC) scores
Time Frame: 2 weeks
For measurements of 5 behavioral domains including irritability, social withdrawal, stereotypy, hyperactivity and inappropriate speech
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuropix

Investigators

  • Principal Investigator: Daniel Ko, PhD, Neuropix

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 10, 2026

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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