Autism Spectrum DisorderNCT06473623
Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder
A study testing vagus nerve stimulation in people with Autism Spectrum Disorder, run by Neuropix at 1 site in Hong Kong.
Trial summary
Non-invasive vagus nerve stimulation for the symptomatic improvements in Autism Spectrum Disorder Read more about this study
- Who is it for?
- Ages 7 to 26 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Angela Peng, Bsc contact
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Science Park
Tai Po
Daniel Ko, PhD, +8525530821, support@neuro-pix.com
About this study
Official title: 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
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- vagus nerve stimulation
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vagus nerve stimulationDevice
Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Receiving intervention of the non-invasive neurostimulation device. Receives: Device: vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility for completed treatments and stimulation intensity tolerance
Completion success and neurostimulation tolerance
Measured: 2 weeks
Secondary outcomes (4)
Clinician Global Clinical Impression (CGI-I)
For core social impairment and overall level of cognitive, adaptive and social functioning
Measured: 2 weeks
Clinician Global Impression Severity (CGI-S)
For assessment of anxiety, gastrointestinal symptoms and social interactions and overall ASD
Measured: 2 weeks
Parent-Rated Anxiety Scale for ASD (PRAS-ASD)
For anxiety assessment consisting of 25 questions related to anxiety ranging from 0 (none) to 3 (severe)
Measured: 2 weeks
Autistic Behavior Checklist (ABC) scores
For measurements of 5 behavioral domains including irritability, social withdrawal, stereotypy, hyperactivity and inappropriate speech
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Dec 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuropix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Ko, PhD, Principal investigator, Neuropix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473623
- Sponsor's protocol ID
- 01A
- Status last verified
- Jan 2026
- First submitted
- 19 Jun 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28163670Black 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.
PubMed 37840787Molero-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.
PubMed 35053839
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder: An Open-Label Trial
- ClinicalTrials.gov ID
- NCT06473623
- Acronym / sponsor ID
- 01A
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NeuropixIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-invasive vagus nerve stimulation for the symptomatic improvements in Autism Spectrum Disorder
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: vagus nerve stimulationReceiving intervention of the non-invasive neurostimulation device. |
Who may qualify
- Ages
- 7 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vagus nerve stimulationNon-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) | Device | Treatment Arm |
Primary outcome
Feasibility for completed treatments and stimulation intensity tolerance
Time frame: 2 weeks
Completion success and neurostimulation tolerance
4 secondary outcomes
Clinician Global Clinical Impression (CGI-I)
Time frame: 2 weeks
Clinician Global Impression Severity (CGI-S)
Time frame: 2 weeks
Parent-Rated Anxiety Scale for ASD (PRAS-ASD)
Time frame: 2 weeks
Autistic Behavior Checklist (ABC) scores
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 28163670Jin 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.
- Background: PubMed 37840787Black 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.
- Background: PubMed 35053839Molero-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.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Peng, Bsc contact
Daniel Ko, PhD principal investigator
Neuropix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vagus nerve stimulation in people with Autism Spectrum Disorder, run by Neuropix at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Ko, PhD (+85255308212, danielko@neuro-pix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility for completed treatments and stimulation intensity tolerance (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06473623, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.