Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder
NCT ID: NCT06473623
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-12-01
2026-02-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Treatment Arm
Receiving intervention of the non-invasive neurostimulation device.
vagus nerve stimulation
Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS)
Interventions
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vagus nerve stimulation
Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS)
Eligibility Criteria
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Inclusion Criteria
* 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 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
7 Years
26 Years
ALL
No
Sponsors
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Neuropix
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Ko, PhD
Role: PRINCIPAL_INVESTIGATOR
Neuropix
Locations
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Hong Kong Science Park
Tai Po, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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Jin Y, Kong J. Transcutaneous Vagus Nerve Stimulation: A Promising Method for Treatment of Autism Spectrum Disorders. Front Neurosci. 2017 Jan 20;10:609. doi: 10.3389/fnins.2016.00609. eCollection 2016.
Black B, Hunter S, Cottrell H, Dar R, Takahashi N, Ferguson BJ, Valter Y, Porges E, Datta A, Beversdorf DQ. Remotely supervised at-home delivery of taVNS for autism spectrum disorder: feasibility and initial efficacy. Front Psychiatry. 2023 Sep 28;14:1238328. doi: 10.3389/fpsyt.2023.1238328. eCollection 2023.
Molero-Chamizo A, Nitsche MA, Bolz A, Andujar Barroso RT, Alameda Bailen JR, Garcia Palomeque JC, Rivera-Urbina GN. Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol. Brain Sci. 2022 Jan 12;12(1):95. doi: 10.3390/brainsci12010095.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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01A
Identifier Type: -
Identifier Source: org_study_id
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