NCT06473623

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

June 19, 2024

Last Update Submit

January 5, 2026

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • Feasibility for completed treatments and stimulation intensity tolerance

    Completion success and neurostimulation tolerance

    2 weeks

Secondary Outcomes (4)

  • Clinician Global Clinical Impression (CGI-I)

    2 weeks

  • Clinician Global Impression Severity (CGI-S)

    2 weeks

  • Parent-Rated Anxiety Scale for ASD (PRAS-ASD)

    2 weeks

  • Autistic Behavior Checklist (ABC) scores

    2 weeks

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Receiving intervention of the non-invasive neurostimulation device.

Device: vagus nerve stimulation

Interventions

vagus nerve stimulationDEVICE

Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS)

Treatment Arm

Eligibility Criteria

Age7 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Science Park

Tai Po, Hong Kong

RECRUITING

Related Publications (3)

  • 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.

    PMID: 28163670BACKGROUND

  • 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.

    PMID: 37840787BACKGROUND

  • 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.

    PMID: 35053839BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Officials

  • Daniel Ko, PhD

    Neuropix

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Ko, PhD

CONTACT

+85255308212danielko@neuro-pix.com

Angela Peng, Bsc

CONTACT

angelapeng@neuropix.co

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2024

First Posted

June 25, 2024

Study Start

December 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 10, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)