RecruitingNot ApplicableNCT06473623

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


Sponsor

Neuropix

Enrollment

20 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 7 YearsMax Age: 26 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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

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Interventions

DEVICEvagus nerve stimulation

Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS)


Locations(1)

Hong Kong Science Park

Tai Po, Hong Kong

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NCT06473623


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